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701 Pennsylvania Avenue, NW Suite 800 Washington, D.C. 20004–2654 Tel: 202 783 8700 Fax: 202 783 8750 www.AdvaMed.org
Bringing innovation to patient care worldwide
February 26, 2018
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Re: Docket No. FDA-2017-N-6730: Voluntary Malfunction Summary Reporting Program
for Manufacturers, Notice and Request for Comments
To Whom It May Concern:
The Advanced Medical Technology Association (“AdvaMed”) appreciates the opportunity to
provide comment on the Food and Drug Administration’s (“FDA” or “Agency”) Notice and
request for comments, Voluntary Malfunction Summary Reporting Program for
Manufacturers (“Notice”).1 AdvaMed represents manufacturers of medical devices and
diagnostic products that are transforming health care through earlier disease detection, less
invasive procedures, and more effective treatment. Our members range from the smallest to
the largest medical technology innovators and companies.
AdvaMed commends the Agency for establishing a summary reporting program for device
malfunctions. Not only will this program, when fully implemented, fulfill the Agency’s
commitment under the MDUFA IV Commitment Letter to establish criteria to streamline
MDR requirements for “most, if not all” device procodes,”2 it will also fulfill the Agency’s
longstanding statutory directive for summary, quarterly reporting under section 227 of the
Food and Drug Administration Amendments Act of 2007.3
Implementation of a summary malfunction program will facilitate FDA’s and industry’s
increased focus on the subset of device malfunctions that are more likely to identify new
information about device safety or efficacy. Summary malfunction reports will greatly
reduce the volume of reports that manufacturers would need to submit to FDA, streamline
the information FDA receives, which will facilitate more efficient understanding of potential
malfunction issues, and for the public, will allow event trends for a particular device to be
more readily transparent.
In the interest of implementing this program within the MDUFA IV Commitment timeframe,
we support FDA’s use of Form 3500A for information submission purposes, with several
recommendations in the attached document. However, we do not believe Form 3500A
1 Voluntary Malfunction Summary Reporting Program for Manufacturers, Notice and Request for Comments
(Dec. 26, 2017), available at https://www.gpo.gov/fdsys/pkg/FR-2017-12-26/pdf/2017-27650.pdf.
2 Available at https://www.fda.gov/downloads/ForIndustry/UserFees/MedicalDeviceUserFee/UCM526395.pdf.
3 Pub. L. No. 110-85
Docket No. FDA-2017-N-6730
February 26, 2018
Page 2 of 50
represents the most appropriate mechanism to submit summary malfunction information, and
as a result, we ask that FDA work with industry to develop a more tailored reporting form
that will better convey the reportable information.
We agree that the type of device malfunctions that should be eligible for summary reporting
should be limited to those already known to the manufacturer and FDA. In this regard, when
a new type of malfunction occurs that the manufacturer has not previously reported to FDA,
the manufacturer would submit an individual report.4 This proposal represents a common-
sense approach to summary malfunction reporting because, typically, the most common
malfunctions for a device have been thoroughly investigated and assessed by the company,
frequently reviewed by FDA, and are often identified in the device labeling. In these
instances, individual reports of the occurrence of the same malfunction hold little, if any,
analytical value; rather, quarterly reporting for these malfunctions allows for appropriate
monitoring of trends and volumes.
AdvaMed believes the following criteria should be used by FDA to determine procode
eligibility for this program. Procodes that meet any of the following criteria should be
eligible for summary, quarterly malfunction reporting:
• All Class I devices;
• All Class II devices that are not implantable, life-sustaining, or life-supporting;
• Class II devices that are implantable, life-sustaining, or life supporting, and Class III
devices, if they have had a procode for two years or more (or, if there has been a new
procode issued in the last two years, but it was issued for administrative or other
reasons, and the new procode is not representative of a new technology).
We believe this approach provides FDA the opportunity to gain experience with a new device
technology and study the nature and extent of any unanticipated malfunctions for such device
types. New procodes should automatically transition to summary, quarterly malfunction
reporting two years after the approval or clearance date of the first device within the procode,
unless FDA publishes a notice indicating why the procode should not be eligible to transition
to summary, quarterly reporting. We recommend that FDA publish a notice in the Federal
Register when a new procode is established and explain when a new procode does not
represent a new technology and is thus eligible on the same timetable as the procode from
which it derived.
Furthermore, we encourage FDA to develop a streamlined mechanism for manufacturers and
other stakeholders to identify additional procodes that should be eligible for quarterly
reporting (other than those that fall within the criteria above), as well as to identify any
eligible procodes for which there might be a basis to revisit whether quarterly reporting is
appropriate. The list of eligible procodes that FDA maintains should be kept up to date and
should provide historical information concerning changes to the list. We also encourage
4 See MDUFA IV Commitment Letter, Section IV.H.3.c.
Docket No. FDA-2017-N-6730
February 26, 2018
Page 3 of 50
FDA to revisit standard malfunction reporting for new procodes after a set period of time,
such as through the new Quality Management audit program.
Our specific comments to the Notice can be found within the attached chart. We have also
attached a list of the procodes we believe should be eligible for summary malfunction
reporting based on our proposal above, in addition to a list of procodes we believe would not
currently be eligible for summary malfunction reporting.
* * *
AdvaMed would like to thank the FDA for its consideration of these comments. Please do
not hesitate to contact me at 202-434-7224 or [email protected] if you have any
questions.
Respectfully submitted,
/s/
Zachary A. Rothstein, Esq.
Associate Vice President
Technology and Regulatory Affairs
Attachments
Docket No. FDA-2017-N-6730
February 26, 2018
Page 4 of 50
Proposed List of Ineligible Procodes
The following list identifies procodes that we believe should be initially ineligible from
summary, quarterly reporting. The list identifies, to the best of our ability, all procodes that
have been issued within the past two years (as of February 26, 2016), except for those that
were issued for administrative (e.g., non-technology) purposes. In order to generate this list,
we reviewed FDA’s public-facing De Novo and PMA databases. For the De Novo database,
we searched for all approvals issued since February 26, 2016. For the PMA database, we
searched for all original PMA approvals issued since February 26, 2016. We then cross-
checked the procodes derived from both searches with the De Novo, PMA and 510(k)
databases to confirm they have been used for less than two years.
1. NOY
2. OAG
3. ONV
4. ONY
5. OTL
6. OYF
7. OYX
8. OZP
9. PKR
10. PLU
11. PLX
12. PLZ
13. PMN
14. PMT
15. PMU
16. PMW
17. PNA
18. PNB
19. PNF
20. PNI
21. PNJ
22. PNK
23. PNL
24. PNQ
25. PNU
26. PNW
27. PNY
28. PNZ
29. POD
30. POH
31. POK
32. POL
33. POM
34. POP
35. POS
36. PPU
37. PPW
38. PQA
39. PQI
40. PQJ
41. PQM
42. PQN
43. PQO
44. PQP
45. PQW
46. PRA
47. PRB
48. PRC
49. PRD
50. PRH
51. PRL
52. PSL
53. PSR
54. PSU
55. PSY
56. PTA
57. PUJ
58. PUM
59. PWB
60. PWD
61. PWE
62. PYN
63. PYX
64. PZE
65. PZF
66. PZJ
67. PZK
68. PZL
69. PZM
70. PZP
71. PZQ
72. PZR
73. QAA
74. QAD
Proposed List of Eligible Procodes
Docket No. FDA-2017-N-6730
February 26, 2018
Page 5 of 50
The following list identifies procodes that we believe should be eligible for summary,
quarterly reporting. To generate this list, we downloaded FDA’s list of procodes and
removed those listed in the above “Ineligible” list.
1. BRT
2. BRW
3. BRX
4. BRY
5. BRZ
6. BSA
7. BSB
8. BSD
9. BSE
10. BSF
11. BSI
12. BSJ
13. BSK
14. BSN
15. BSO
16. BSP
17. BSR
18. BSS
19. BST
20. BSY
21. BSZ
22. BTA
23. BTB
24. BTC
25. BTG
26. BTI
27. BTK
28. BTL
29. BTM
30. BTO
31. BTP
32. BTQ
33. BTR
34. BTS
35. BTT
36. BTX
37. BTY
38. BWA
39. BWB
40. BWC
41. BWF
42. BWH
43. BWJ
44. BWK
45. BWL
46. BWN
47. BWP
48. BXA
49. BXB
50. BXH
51. BXJ
52. BXK
53. BXL
54. BXM
55. BXN
56. BXO
57. BXP
58. BXQ
59. BXR
60. BXW
61. BXX
62. BXY
63. BYD
64. BYE
65. BYF
66. BYG
67. BYH
68. BYI
69. BYJ
70. BYK
71. BYL
72. BYM
73. BYN
74. BYO
75. BYP
76. BYR
77. BYS
78. BYT
79. BYW
80. BYX
81. BYY
82. BYZ
83. BZA
84. BZB
85. BZC
86. BZD
87. BZE
88. BZG
89. BZH
90. BZK
91. BZL
92. BZM
93. BZN
94. BZO
95. BZQ
96. BZR
97. BZS
98. BZT
99. BZW
100. CAC
101. CAD
102. CAE
103. CAF
104. CAG
105. CAH
106. CAI
107. CAK
108. CAL
109. CAM
110. CAN
111. CAO
112. CAP
113. CAR
114. CAT
115. CAW
116. CAX
117. CAZ
118. CBA
119. CBC
120. CBD
121. CBF
122. CBG
123. CBH
124. CBI
125. CBK
126. CBL
Docket No. FDA-2017-N-6730
February 26, 2018
Page 6 of 50
127. CBN
128. CBO
129. CBP
130. CBQ
131. CBR
132. CBS
133. CBT
134. CBZ
135. CCC
136. CCE
137. CCI
138. CCJ
139. CCK
140. CCL
141. CCM
142. CCN
143. CCO
144. CCQ
145. CCT
146. CCW
147. CCX
148. CCY
149. CCZ
150. CDA
151. CDB
152. CDC
153. CDD
154. CDE
155. CDF
156. CDG
157. CDH
158. CDK
159. CDL
160. CDM
161. CDN
162. CDO
163. CDP
164. CDQ
165. CDR
166. CDS
167. CDT
168. CDW
169. CDX
170. CDZ
171. CEA
172. CEC
173. CED
174. CEE
175. CEF
176. CEI
177. CEJ
178. CEK
179. CEL
180. CEM
181. CEN
182. CEO
183. CEP
184. CEQ
185. CER
186. CES
187. CET
188. CEW
189. CEX
190. CFA
191. CFB
192. CFD
193. CFE
194. CFF
195. CFG
196. CFH
197. CFJ
198. CFL
199. CFM
200. CFN
201. CFO
202. CFP
203. CFQ
204. CFR
205. CFT
206. CFW
207. CGA
208. CGC
209. CGD
210. CGE
211. CGF
212. CGH
213. CGI
214. CGJ
215. CGL
216. CGM
217. CGN
218. CGO
219. CGR
220. CGS
221. CGT
222. CGX
223. CGZ
224. CHA
225. CHC
226. CHD
227. CHE
228. CHG
229. CHH
230. CHI
231. CHJ
232. CHK
233. CHL
234. CHM
235. CHN
236. CHO
237. CHP
238. CHQ
239. CHR
240. CHS
241. CHT
242. CHW
243. CHZ
244. CIA
245. CIB
246. CIC
247. CID
248. CIE
249. CIF
250. CIG
251. CIJ
252. CIK
253. CIL
254. CIN
255. CIO
256. CIQ
257. CIS
258. CIT
259. CIW
260. CIX
261. CIY
262. CIZ
263. CJA
264. CJB
Docket No. FDA-2017-N-6730
February 26, 2018
Page 7 of 50
265. CJC
266. CJD
267. CJE
268. CJF
269. CJG
270. CJH
271. CJI
272. CJJ
273. CJK
274. CJL
275. CJM
276. CJN
277. CJO
278. CJQ
279. CJR
280. CJT
281. CJW
282. CJX
283. CJY
284. CJZ
285. CKA
286. CKB
287. CKC
288. CKD
289. CKE
290. CKF
291. CKG
292. CKH
293. CZJ
294. CZK
295. CZL
296. CZM
297. CZN
298. CZO
299. CZP
300. CZQ
301. CZR
302. CZS
303. CZT
304. CZW
305. CZX
306. CZY
307. CZZ
308. DAA
309. DAB
310. DAC
311. DAD
312. DAE
313. DAF
314. DAG
315. DAH
316. DAI
317. DAJ
318. DAK
319. DAL
320. DAM
321. DAN
322. DAO
323. DAP
324. DAQ
325. DAR
326. DAS
327. DAT
328. DAW
329. DAX
330. DAY
331. DAZ
332. DBA
333. DBC
334. DBE
335. DBF
336. DBH
337. DBI
338. DBJ
339. DBK
340. DBL
341. DBM
342. DBN
343. DBT
344. DBY
345. DCB
346. DCE
347. DCF
348. DCH
349. DCJ
350. DCK
351. DCN
352. DCO
353. DCT
354. DCY
355. DDB
356. DDC
357. DDD
358. DDE
359. DDF
360. DDG
361. DDH
362. DDI
363. DDJ
364. DDK
365. DDL
366. DDN
367. DDO
368. DDQ
369. DDR
370. DDS
371. DDT
372. DDX
373. DDY
374. DDZ
375. DEA
376. DEB
377. DEC
378. DEF
379. DEG
380. DEH
381. DEI
382. DEJ
383. DEK
384. DEL
385. DEM
386. DEN
387. DEO
388. DEP
389. DER
390. DES
391. DET
392. DEW
393. DEX
394. DEY
395. DEZ
396. DFB
397. DFC
398. DFD
399. DFF
400. DFG
401. DFH
402. DFI
Docket No. FDA-2017-N-6730
February 26, 2018
Page 8 of 50
403. DFJ
404. DFK
405. DFL
406. DFM
407. DFO
408. DFQ
409. DFS
410. DFT
411. DFX
412. DFZ
413. DGA
414. DGB
415. DGC
416. DGD
417. DGE
418. DGG
419. DGH
420. DGI
421. DGJ
422. DGK
423. DGL
424. DGM
425. DGN
426. DGO
427. DGP
428. DGQ
429. DGR
430. DGW
431. DGX
432. DHA
433. DHB
434. DHC
435. DHF
436. DHI
437. DHL
438. DHN
439. DHQ
440. DHR
441. DHX
442. DHY
443. DIC
444. DID
445. DIE
446. DIF
447. DIG
448. DIH
449. DII
450. DIJ
451. DIK
452. DIL
453. DIM
454. DIN
455. DIO
456. DIP
457. DIQ
458. DIR
459. DIS
460. DIT
461. DIW
462. DIX
463. DIY
464. DIZ
465. DJA
466. DJB
467. DJC
468. DJD
469. DJE
470. DJF
471. DJG
472. DJH
473. DJI
474. DJJ
475. DJK
476. DJL
477. DJM
478. DJN
479. DJO
480. DJP
481. DJQ
482. DJR
483. DJS
484. DJW
485. DJX
486. DJY
487. DJZ
488. DKA
489. DKB
490. DKC
491. DKD
492. DKE
493. DKG
494. DKH
495. DKJ
496. DKK
497. DKN
498. DKO
499. DKP
500. DKQ
501. DKR
502. DKS
503. DKT
504. DKW
505. DKX
506. DKY
507. DKZ
508. DLA
509. DLB
510. DLC
511. DLD
512. DLE
513. DLF
514. DLG
515. DLH
516. DLI
517. DLJ
518. DLN
519. DLO
520. DLP
521. DLR
522. DLS
523. DLT
524. DLX
525. DLY
526. DLZ
527. DMB
528. DMF
529. DMG
530. DMI
531. DMJ
532. DMK
533. DML
534. DMN
535. DMP
536. DMQ
537. DMR
538. DMS
539. DMT
540. DMX
Docket No. FDA-2017-N-6730
February 26, 2018
Page 9 of 50
541. DMY
542. DMZ
543. DNA
544. DNC
545. DND
546. DNE
547. DNF
548. DNG
549. DNH
550. DNI
551. DNJ
552. DNK
553. DNL
554. DNN
555. DNO
556. DNP
557. DNQ
558. DNS
559. DNT
560. DNW
561. DNX
562. DNZ
563. DOA
564. DOB
565. DOD
566. DOE
567. DOF
568. DOG
569. DOH
570. DOJ
571. DOK
572. DOL
573. DOM
574. DON
575. DOO
576. DOP
577. DOR
578. DOS
579. DOW
580. DOX
581. DOY
582. DOZ
583. DPA
584. DPB
585. DPD
586. DPE
587. DPG
588. DPH
589. DPI
590. DPJ
591. DPK
592. DPL
593. DPM
594. DPN
595. DPO
596. DPP
597. DPQ
598. DPS
599. DPT
600. DPW
601. DPZ
602. DQA
603. DQB
604. DQC
605. DQD
606. DQE
607. DQF
608. DQG
609. DQH
610. DQI
611. DQK
612. DQO
613. DQP
614. DQR
615. DQT
616. DQX
617. DQY
618. DRA
619. DRB
620. DRC
621. DRE
622. DRF
623. DRG
624. DRI
625. DRJ
626. DRK
627. DRL
628. DRM
629. DRN
630. DRO
631. DRP
632. DRQ
633. DRR
634. DRS
635. DRT
636. DRW
637. DRX
638. DRY
639. DRZ
640. DSA
641. DSB
642. DSF
643. DSH
644. DSI
645. DSJ
646. DSK
647. DSM
648. DSP
649. DSQ
650. DSR
651. DSS
652. DST
653. DSW
654. DSY
655. DSZ
656. DTA
657. DTB
658. DTC
659. DTD
660. DTE
661. DTF
662. DTG
663. DTH
664. DTI
665. DTJ
666. DTK
667. DTL
668. DTM
669. DTN
670. DTP
671. DTQ
672. DTR
673. DTS
674. DTW
675. DTX
676. DTY
677. DTZ
678. DWA
Docket No. FDA-2017-N-6730
February 26, 2018
Page 10 of 50
679. DWB
680. DWC
681. DWD
682. DWE
683. DWF
684. DWG
685. DWH
686. DWI
687. DWJ
688. DWL
689. DWM
690. DWO
691. DWP
692. DWQ
693. DWS
694. DWX
695. DWZ
696. DXC
697. DXE
698. DXF
699. DXG
700. DXH
701. DXJ
702. DXK
703. DXL
704. DXM
705. DXN
706. DXO
707. DXP
708. DXQ
709. DXR
710. DXS
711. DXT
712. DXW
713. DXX
714. DXY
715. DXZ
716. DYB
717. DYC
718. DYE
719. DYF
720. DYG
721. DYH
722. DYJ
723. DYN
724. DYO
725. DYT
726. DYW
727. DYX
728. DZA
729. DZB
730. DZC
731. DZD
732. DZE
733. DZG
734. DZH
735. DZI
736. DZJ
737. DZK
738. DZL
739. DZM
740. DZN
741. DZP
742. DZS
743. EAG
744. EAH
745. EAJ
746. EAK
747. EAM
748. EAP
749. EAQ
750. EAS
751. EAT
752. EAX
753. EAY
754. EAZ
755. EBA
756. EBC
757. EBD
758. EBE
759. EBF
760. EBG
761. EBH
762. EBI
763. EBL
764. EBO
765. EBP
766. EBR
767. EBW
768. EBZ
769. ECB
770. ECC
771. ECG
772. ECI
773. ECM
774. ECN
775. ECO
776. ECP
777. ECQ
778. ECR
779. ECS
780. ECT
781. ECX
782. EEA
783. EEF
784. EEG
785. EEJ
786. EFA
787. EFB
788. EFC
789. EFD
790. EFH
791. EFK
792. EFL
793. EFN
794. EFQ
795. EFS
796. EFT
797. EFW
798. EFX
799. EGD
800. EGG
801. EGI
802. EGJ
803. EGM
804. EGN
805. EGQ
806. EGS
807. EGT
808. EGW
809. EGY
810. EGZ
811. EHA
812. EHB
813. EHD
814. EHE
815. EHJ
816. EHK
Docket No. FDA-2017-N-6730
February 26, 2018
Page 11 of 50
817. EHL
818. EHM
819. EHO
820. EHP
821. EHQ
822. EHR
823. EHS
824. EHY
825. EHZ
826. EIA
827. EIB
828. EIC
829. EID
830. EIE
831. EIF
832. EIG
833. EIH
834. EIK
835. EIL
836. EIR
837. EIS
838. EIT
839. EIX
840. EIY
841. EJB
842. EJE
843. EJF
844. EJG
845. EJH
846. EJI
847. EJJ
848. EJK
849. EJL
850. EJP
851. EJQ
852. EJR
853. EJS
854. EJT
855. EJW
856. EJX
857. EJY
858. EJZ
859. EKA
860. EKB
861. EKC
862. EKD
863. EKE
864. EKF
865. EKG
866. EKH
867. EKI
868. EKJ
869. EKK
870. EKL
871. EKM
872. EKN
873. EKO
874. EKP
875. EKQ
876. EKR
877. EKS
878. EKT
879. EKW
880. EKX
881. EKY
882. EKZ
883. ELA
884. ELB
885. ELC
886. ELE
887. ELJ
888. ELK
889. ELL
890. ELM
891. ELN
892. ELO
893. ELR
894. ELS
895. ELW
896. ELY
897. ELZ
898. EMA
899. EMB
900. EMD
901. EME
902. EMF
903. EMG
904. EMH
905. EMI
906. EMJ
907. EMK
908. EML
909. EMM
910. EMN
911. EMO
912. EMP
913. EMQ
914. EMR
915. EMS
916. EMX
917. ENW
918. ENZ
919. EOB
920. EOQ
921. EOX
922. EPE
923. EPF
924. EPG
925. EPN
926. EPP
927. EPT
928. EPW
929. EPY
930. EQH
931. EQJ
932. EQL
933. EQN
934. ERA
935. ERL
936. ERY
937. ESD
938. ESE
939. ESF
940. ESH
941. ESI
942. ESW
943. ESX
944. ESZ
945. ETA
946. ETB
947. ETC
948. ETD
949. ETF
950. ETK
951. ETM
952. ETN
953. ETP
954. ETR
Docket No. FDA-2017-N-6730
February 26, 2018
Page 12 of 50
955. ETS
956. ETT
957. ETW
958. ETY
959. EWA
960. EWC
961. EWD
962. EWE
963. EWG
964. EWL
965. EWO
966. EWQ
967. EWT
968. EWW
969. EWY
970. EXA
971. EXB
972. EXD
973. EXE
974. EXF
975. EXG
976. EXH
977. EXI
978. EXJ
979. EXM
980. EXN
981. EXQ
982. EXR
983. EXS
984. EXW
985. EXX
986. EXY
987. EXZ
988. EYA
989. EYB
990. EYC
991. EYD
992. EYF
993. EYH
994. EYI
995. EYJ
996. EYK
997. EYN
998. EYQ
999. EYR
1000. EYS
1001. EYT
1002. EYX
1003. EYY
1004. EYZ
1005. EZB
1006. EZC
1007. EZD
1008. EZK
1009. EZL
1010. EZM
1011. EZN
1012. EZO
1013. EZP
1014. EZQ
1015. EZR
1016. EZS
1017. EZT
1018. EZW
1019. EZX
1020. EZY
1021. EZZ
1022. FAA
1023. FAB
1024. FAC
1025. FAD
1026. FAE
1027. FAF
1028. FAG
1029. FAH
1030. FAJ
1031. FAK
1032. FAL
1033. FAM
1034. FAN
1035. FAO
1036. FAP
1037. FAQ
1038. FAR
1039. FAS
1040. FAT
1041. FAX
1042. FAZ
1043. FBI
1044. FBJ
1045. FBK
1046. FBM
1047. FBN
1048. FBO
1049. FBP
1050. FBQ
1051. FBR
1052. FBS
1053. FBW
1054. FBX
1055. FBY
1056. FBZ
1057. FCB
1058. FCC
1059. FCD
1060. FCE
1061. FCF
1062. FCG
1063. FCH
1064. FCI
1065. FCK
1066. FCL
1067. FCM
1068. FCN
1069. FCO
1070. FCP
1071. FCQ
1072. FCR
1073. FCS
1074. FCT
1075. FCW
1076. FCX
1077. FCY
1078. FCZ
1079. FDA
1080. FDB
1081. FDC
1082. FDE
1083. FDF
1084. FDG
1085. FDI
1086. FDJ
1087. FDL
1088. FDP
1089. FDR
1090. FDS
1091. FDT
1092. FDW
Docket No. FDA-2017-N-6730
February 26, 2018
Page 13 of 50
1093. FDX
1094. FDY
1095. FDZ
1096. FEA
1097. FEB
1098. FEC
1099. FED
1100. FEF
1101. FEG
1102. FEH
1103. FEI
1104. FEJ
1105. FEM
1106. FEN
1107. FEO
1108. FEQ
1109. FER
1110. FES
1111. FET
1112. FEW
1113. FEX
1114. FEZ
1115. FFA
1116. FFD
1117. FFE
1118. FFF
1119. FFG
1120. FFH
1121. FFI
1122. FFK
1123. FFL
1124. FFN
1125. FFO
1126. FFP
1127. FFQ
1128. FFR
1129. FFS
1130. FFT
1131. FFW
1132. FFX
1133. FFY
1134. FFZ
1135. FGA
1136. FGB
1137. FGC
1138. FGD
1139. FGE
1140. FGF
1141. FGH
1142. FGI
1143. FGK
1144. FGM
1145. FGN
1146. FGO
1147. FGS
1148. FGW
1149. FGX
1150. FGY
1151. FHA
1152. FHB
1153. FHC
1154. FHF
1155. FHG
1156. FHH
1157. FHI
1158. FHJ
1159. FHK
1160. FHL
1161. FHM
1162. FHN
1163. FHO
1164. FHP
1165. FHQ
1166. FHR
1167. FHS
1168. FHT
1169. FHW
1170. FHX
1171. FHY
1172. FHZ
1173. FIA
1174. FIB
1175. FID
1176. FIE
1177. FIF
1178. FIG
1179. FIH
1180. FII
1181. FIJ
1182. FIK
1183. FIL
1184. FIN
1185. FIP
1186. FIQ
1187. FIR
1188. FIS
1189. FIW
1190. FIZ
1191. FJA
1192. FJB
1193. FJC
1194. FJD
1195. FJF
1196. FJG
1197. FJH
1198. FJI
1199. FJJ
1200. FJK
1201. FJL
1202. FJM
1203. FJN
1204. FJO
1205. FJP
1206. FJQ
1207. FJR
1208. FJS
1209. FJT
1210. FJW
1211. FJX
1212. FJY
1213. FJZ
1214. FKA
1215. FKB
1216. FKC
1217. FKD
1218. FKE
1219. FKF
1220. FKG
1221. FKH
1222. FKI
1223. FKJ
1224. FKK
1225. FKL
1226. FKM
1227. FKN
1228. FKO
1229. FKP
1230. FKQ
Docket No. FDA-2017-N-6730
February 26, 2018
Page 14 of 50
1231. FKR
1232. FKT
1233. FKW
1234. FKX
1235. FKY
1236. FLA
1237. FLB
1238. FLC
1239. FLD
1240. FLE
1241. FLF
1242. FLG
1243. FLH
1244. FLI
1245. FLJ
1246. FLK
1247. FLL
1248. FLN
1249. FLS
1250. FMA
1251. FMC
1252. FME
1253. FMF
1254. FMG
1255. FMH
1256. FMI
1257. FMJ
1258. FMK
1259. FML
1260. FMP
1261. FMQ
1262. FMR
1263. FMS
1264. FMT
1265. FMW
1266. FMZ
1267. FNC
1268. FNG
1269. FNJ
1270. FNK
1271. FNL
1272. FNM
1273. FNN
1274. FNP
1275. FNS
1276. FNW
1277. FNY
1278. FOA
1279. FOB
1280. FOC
1281. FOD
1282. FOG
1283. FOH
1284. FOK
1285. FON
1286. FOS
1287. FOX
1288. FOZ
1289. FPA
1290. FPB
1291. FPD
1292. FPF
1293. FPK
1294. FPL
1295. FPO
1296. FPP
1297. FPS
1298. FPX
1299. FPY
1300. FQA
1301. FQH
1302. FQJ
1303. FQK
1304. FQL
1305. FQM
1306. FQO
1307. FQP
1308. FQZ
1309. FRA
1310. FRC
1311. FRF
1312. FRG
1313. FRI
1314. FRJ
1315. FRK
1316. FRL
1317. FRN
1318. FRO
1319. FRP
1320. FRQ
1321. FRR
1322. FRT
1323. FRW
1324. FRZ
1325. FSA
1326. FSD
1327. FSE
1328. FSH
1329. FSM
1330. FSO
1331. FSP
1332. FSQ
1333. FSR
1334. FSS
1335. FST
1336. FSW
1337. FSX
1338. FSY
1339. FSZ
1340. FTA
1341. FTC
1342. FTD
1343. FTF
1344. FTG
1345. FTH
1346. FTI
1347. FTJ
1348. FTL
1349. FTM
1350. FTN
1351. FTO
1352. FTQ
1353. FTR
1354. FTS
1355. FTT
1356. FTX
1357. FTY
1358. FTZ
1359. FWB
1360. FWC
1361. FWD
1362. FWE
1363. FWF
1364. FWG
1365. FWH
1366. FWI
1367. FWJ
1368. FWK
Docket No. FDA-2017-N-6730
February 26, 2018
Page 15 of 50
1369. FWL
1370. FWM
1371. FWN
1372. FWP
1373. FWW
1374. FWX
1375. FWY
1376. FWZ
1377. FXE
1378. FXF
1379. FXG
1380. FXM
1381. FXN
1382. FXO
1383. FXP
1384. FXQ
1385. FXR
1386. FXS
1387. FXT
1388. FXW
1389. FXX
1390. FXY
1391. FXZ
1392. FYA
1393. FYB
1394. FYC
1395. FYD
1396. FYE
1397. FYF
1398. FYH
1399. FYI
1400. FZC
1401. FZD
1402. FZE
1403. FZF
1404. FZG
1405. FZH
1406. FZI
1407. FZK
1408. FZM
1409. FZO
1410. FZP
1411. FZQ
1412. FZR
1413. FZS
1414. FZT
1415. FZW
1416. FZX
1417. FZY
1418. FZZ
1419. GAA
1420. GAB
1421. GAC
1422. GAD
1423. GAE
1424. GAF
1425. GAG
1426. GAH
1427. GAI
1428. GAJ
1429. GAK
1430. GAL
1431. GAM
1432. GAN
1433. GAO
1434. GAP
1435. GAQ
1436. GAR
1437. GAS
1438. GAT
1439. GAW
1440. GAX
1441. GAZ
1442. GBA
1443. GBB
1444. GBC
1445. GBI
1446. GBJ
1447. GBL
1448. GBM
1449. GBN
1450. GBO
1451. GBP
1452. GBQ
1453. GBS
1454. GBT
1455. GBW
1456. GBX
1457. GBY
1458. GBZ
1459. GCA
1460. GCB
1461. GCC
1462. GCD
1463. GCE
1464. GCF
1465. GCG
1466. GCH
1467. GCI
1468. GCJ
1469. GCK
1470. GCL
1471. GCM
1472. GCN
1473. GCO
1474. GCP
1475. GCQ
1476. GCS
1477. GCT
1478. GCW
1479. GCX
1480. GCY
1481. GCZ
1482. GDB
1483. GDC
1484. GDF
1485. GDG
1486. GDH
1487. GDI
1488. GDJ
1489. GDL
1490. GDM
1491. GDN
1492. GDO
1493. GDR
1494. GDS
1495. GDT
1496. GDW
1497. GDX
1498. GDY
1499. GDZ
1500. GEA
1501. GEC
1502. GED
1503. GEE
1504. GEF
1505. GEG
1506. GEH
Docket No. FDA-2017-N-6730
February 26, 2018
Page 16 of 50
1507. GEI
1508. GEJ
1509. GEL
1510. GEN
1511. GEO
1512. GER
1513. GES
1514. GET
1515. GEX
1516. GEY
1517. GFA
1518. GFB
1519. GFC
1520. GFD
1521. GFE
1522. GFF
1523. GFG
1524. GFI
1525. GFJ
1526. GFK
1527. GFO
1528. GFS
1529. GFT
1530. GFX
1531. GGC
1532. GGF
1533. GGG
1534. GGH
1535. GGJ
1536. GGK
1537. GGL
1538. GGM
1539. GGN
1540. GGO
1541. GGP
1542. GGQ
1543. GGT
1544. GGW
1545. GGX
1546. GGY
1547. GGZ
1548. GHA
1549. GHC
1550. GHD
1551. GHH
1552. GHK
1553. GHM
1554. GHO
1555. GHQ
1556. GHR
1557. GHS
1558. GHY
1559. GHZ
1560. GIA
1561. GIE
1562. GIF
1563. GIG
1564. GII
1565. GIL
1566. GIM
1567. GIO
1568. GIQ
1569. GIR
1570. GIS
1571. GIT
1572. GIZ
1573. GJA
1574. GJB
1575. GJC
1576. GJE
1577. GJG
1578. GJH
1579. GJJ
1580. GJL
1581. GJN
1582. GJP
1583. GJR
1584. GJS
1585. GJT
1586. GJW
1587. GJZ
1588. GKA
1589. GKB
1590. GKE
1591. GKF
1592. GKG
1593. GKH
1594. GKJ
1595. GKK
1596. GKL
1597. GKM
1598. GKN
1599. GKP
1600. GKQ
1601. GKR
1602. GKT
1603. GKW
1604. GKX
1605. GKZ
1606. GLE
1607. GLG
1608. GLK
1609. GLQ
1610. GLY
1611. GLZ
1612. GMA
1613. GMB
1614. GMD
1615. GME
1616. GMG
1617. GMH
1618. GMI
1619. GMJ
1620. GMK
1621. GML
1622. GMM
1623. GMN
1624. GMO
1625. GMP
1626. GMQ
1627. GMR
1628. GMS
1629. GMT
1630. GMW
1631. GMX
1632. GMY
1633. GMZ
1634. GNA
1635. GNB
1636. GNC
1637. GND
1638. GNE
1639. GNF
1640. GNG
1641. GNH
1642. GNI
1643. GNJ
1644. GNK
Docket No. FDA-2017-N-6730
February 26, 2018
Page 17 of 50
1645. GNL
1646. GNM
1647. GNN
1648. GNO
1649. GNP
1650. GNQ
1651. GNR
1652. GNS
1653. GNT
1654. GNW
1655. GNX
1656. GNY
1657. GNZ
1658. GOA
1659. GOB
1660. GOC
1661. GOD
1662. GOE
1663. GOF
1664. GOG
1665. GOH
1666. GOI
1667. GOJ
1668. GOK
1669. GOL
1670. GOM
1671. GON
1672. GOO
1673. GOP
1674. GOS
1675. GOT
1676. GOW
1677. GOX
1678. GOY
1679. GOZ
1680. GPD
1681. GPE
1682. GPF
1683. GPG
1684. GPH
1685. GPI
1686. GPJ
1687. GPK
1688. GPM
1689. GPN
1690. GPO
1691. GPP
1692. GPQ
1693. GPR
1694. GPS
1695. GPT
1696. GPW
1697. GPX
1698. GPY
1699. GPZ
1700. GQA
1701. GQB
1702. GQC
1703. GQD
1704. GQE
1705. GQF
1706. GQG
1707. GQH
1708. GQI
1709. GQJ
1710. GQK
1711. GQL
1712. GQM
1713. GQN
1714. GQO
1715. GQP
1716. GQQ
1717. GQR
1718. GQS
1719. GQT
1720. GQW
1721. GQX
1722. GQY
1723. GQZ
1724. GRA
1725. GRB
1726. GRC
1727. GRD
1728. GRE
1729. GRF
1730. GRG
1731. GRH
1732. GRI
1733. GRJ
1734. GRK
1735. GRL
1736. GRM
1737. GRO
1738. GRP
1739. GRT
1740. GRW
1741. GRX
1742. GRY
1743. GRZ
1744. GSA
1745. GSB
1746. GSD
1747. GSE
1748. GSF
1749. GSG
1750. GSH
1751. GSI
1752. GSJ
1753. GSK
1754. GSL
1755. GSM
1756. GSN
1757. GSO
1758. GSP
1759. GSQ
1760. GSR
1761. GSS
1762. GST
1763. GSW
1764. GSX
1765. GSY
1766. GSZ
1767. GTA
1768. GTB
1769. GTC
1770. GTD
1771. GTE
1772. GTF
1773. GTH
1774. GTI
1775. GTJ
1776. GTL
1777. GTN
1778. GTO
1779. GTP
1780. GTQ
1781. GTR
1782. GTX
Docket No. FDA-2017-N-6730
February 26, 2018
Page 18 of 50
1783. GTY
1784. GTZ
1785. GWB
1786. GWC
1787. GWD
1788. GWE
1789. GWF
1790. GWG
1791. GWI
1792. GWJ
1793. GWK
1794. GWL
1795. GWM
1796. GWN
1797. GWO
1798. GWQ
1799. GWR
1800. GWS
1801. GWW
1802. GWX
1803. GWY
1804. GWZ
1805. GXB
1806. GXC
1807. GXD
1808. GXE
1809. GXH
1810. GXI
1811. GXJ
1812. GXL
1813. GXM
1814. GXN
1815. GXO
1816. GXP
1817. GXQ
1818. GXR
1819. GXS
1820. GXT
1821. GXW
1822. GXX
1823. GXY
1824. GXZ
1825. GYA
1826. GYB
1827. GYC
1828. GYD
1829. GYE
1830. GYK
1831. GYZ
1832. GZA
1833. GZB
1834. GZC
1835. GZD
1836. GZE
1837. GZF
1838. GZI
1839. GZJ
1840. GZK
1841. GZL
1842. GZM
1843. GZN
1844. GZO
1845. GZP
1846. GZQ
1847. GZT
1848. GZX
1849. HAB
1850. HAD
1851. HAE
1852. HAM
1853. HAO
1854. HAS
1855. HAW
1856. HAX
1857. HBA
1858. HBB
1859. HBC
1860. HBD
1861. HBE
1862. HBF
1863. HBG
1864. HBI
1865. HBK
1866. HBL
1867. HBM
1868. HBN
1869. HBO
1870. HBP
1871. HBQ
1872. HBR
1873. HBS
1874. HBT
1875. HBW
1876. HBX
1877. HBZ
1878. HCA
1879. HCB
1880. HCC
1881. HCD
1882. HCE
1883. HCF
1884. HCG
1885. HCH
1886. HCI
1887. HCJ
1888. HCS
1889. HCY
1890. HCZ
1891. HDA
1892. HDB
1893. HDC
1894. HDD
1895. HDE
1896. HDF
1897. HDG
1898. HDH
1899. HDI
1900. HDJ
1901. HDK
1902. HDL
1903. HDM
1904. HDN
1905. HDO
1906. HDP
1907. HDQ
1908. HDR
1909. HDT
1910. HDW
1911. HDX
1912. HDY
1913. HDZ
1914. HEA
1915. HEB
1916. HEC
1917. HED
1918. HEE
1919. HEF
1920. HEG
Docket No. FDA-2017-N-6730
February 26, 2018
Page 19 of 50
1921. HEH
1922. HEI
1923. HEJ
1924. HEK
1925. HEL
1926. HEM
1927. HEN
1928. HEO
1929. HEP
1930. HEQ
1931. HER
1932. HES
1933. HET
1934. HEW
1935. HEX
1936. HEZ
1937. HFA
1938. HFB
1939. HFC
1940. HFD
1941. HFE
1942. HFF
1943. HFG
1944. HFH
1945. HFI
1946. HFJ
1947. HFK
1948. HFL
1949. HFM
1950. HFN
1951. HFO
1952. HFP
1953. HFS
1954. HFW
1955. HFX
1956. HFY
1957. HFZ
1958. HGA
1959. HGB
1960. HGC
1961. HGD
1962. HGE
1963. HGF
1964. HGG
1965. HGH
1966. HGI
1967. HGK
1968. HGL
1969. HGM
1970. HGN
1971. HGO
1972. HGP
1973. HGS
1974. HGW
1975. HGX
1976. HGY
1977. HGZ
1978. HHA
1979. HHD
1980. HHE
1981. HHF
1982. HHG
1983. HHI
1984. HHJ
1985. HHK
1986. HHL
1987. HHM
1988. HHN
1989. HHO
1990. HHP
1991. HHQ
1992. HHR
1993. HHS
1994. HHT
1995. HHW
1996. HHX
1997. HHY
1998. HIB
1999. HIC
2000. HIF
2001. HIG
2002. HIH
2003. HII
2004. HIL
2005. HIM
2006. HIN
2007. HIO
2008. HIQ
2009. HIR
2010. HIS
2011. HIT
2012. HIW
2013. HIX
2014. HIY
2015. HJA
2016. HJB
2017. HJC
2018. HJD
2019. HJE
2020. HJF
2021. HJG
2022. HJH
2023. HJI
2024. HJJ
2025. HJK
2026. HJL
2027. HJM
2028. HJN
2029. HJO
2030. HJQ
2031. HJR
2032. HJS
2033. HJT
2034. HJW
2035. HJX
2036. HJY
2037. HJZ
2038. HKB
2039. HKC
2040. HKD
2041. HKF
2042. HKG
2043. HKI
2044. HKK
2045. HKL
2046. HKM
2047. HKN
2048. HKO
2049. HKP
2050. HKQ
2051. HKR
2052. HKS
2053. HKT
2054. HKW
2055. HKX
2056. HKY
2057. HKZ
2058. HLA
Docket No. FDA-2017-N-6730
February 26, 2018
Page 20 of 50
2059. HLC
2060. HLD
2061. HLE
2062. HLF
2063. HLG
2064. HLH
2065. HLI
2066. HLJ
2067. HLK
2068. HLL
2069. HLM
2070. HLN
2071. HLO
2072. HLP
2073. HLQ
2074. HLR
2075. HLS
2076. HLT
2077. HLW
2078. HLX
2079. HLZ
2080. HMC
2081. HMD
2082. HME
2083. HMF
2084. HMG
2085. HMH
2086. HMJ
2087. HMK
2088. HML
2089. HMM
2090. HMN
2091. HMO
2092. HMP
2093. HMQ
2094. HMR
2095. HMS
2096. HMT
2097. HMW
2098. HMX
2099. HMY
2100. HMZ
2101. HNA
2102. HNB
2103. HNC
2104. HND
2105. HNE
2106. HNF
2107. HNG
2108. HNH
2109. HNI
2110. HNJ
2111. HNK
2112. HNL
2113. HNM
2114. HNN
2115. HNO
2116. HNP
2117. HNQ
2118. HNR
2119. HNS
2120. HNT
2121. HNW
2122. HNX
2123. HNY
2124. HNZ
2125. HOA
2126. HOB
2127. HOC
2128. HOD
2129. HOE
2130. HOF
2131. HOG
2132. HOH
2133. HOI
2134. HOJ
2135. HOK
2136. HOL
2137. HOM
2138. HON
2139. HOO
2140. HOP
2141. HOQ
2142. HOR
2143. HOS
2144. HOT
2145. HOW
2146. HOX
2147. HOY
2148. HOZ
2149. HPA
2150. HPB
2151. HPC
2152. HPD
2153. HPE
2154. HPF
2155. HPG
2156. HPH
2157. HPI
2158. HPJ
2159. HPK
2160. HPL
2161. HPM
2162. HPN
2163. HPO
2164. HPP
2165. HPQ
2166. HPS
2167. HPT
2168. HPW
2169. HPX
2170. HPY
2171. HPZ
2172. HQA
2173. HQB
2174. HQC
2175. HQD
2176. HQE
2177. HQF
2178. HQG
2179. HQH
2180. HQJ
2181. HQL
2182. HQM
2183. HQN
2184. HQO
2185. HQP
2186. HQQ
2187. HQR
2188. HQS
2189. HQT
2190. HQW
2191. HQX
2192. HQY
2193. HQZ
2194. HRB
2195. HRC
2196. HRD
Docket No. FDA-2017-N-6730
February 26, 2018
Page 21 of 50
2197. HRE
2198. HRF
2199. HRG
2200. HRH
2201. HRI
2202. HRJ
2203. HRK
2204. HRL
2205. HRM
2206. HRN
2207. HRO
2208. HRP
2209. HRQ
2210. HRR
2211. HRS
2212. HRT
2213. HRW
2214. HRX
2215. HRY
2216. HRZ
2217. HSA
2218. HSB
2219. HSD
2220. HSH
2221. HSN
2222. HSO
2223. HSP
2224. HSQ
2225. HSR
2226. HSS
2227. HST
2228. HSX
2229. HSZ
2230. HTC
2231. HTD
2232. HTE
2233. HTF
2234. HTG
2235. HTH
2236. HTJ
2237. HTM
2238. HTN
2239. HTO
2240. HTP
2241. HTQ
2242. HTR
2243. HTS
2244. HTT
2245. HTW
2246. HTX
2247. HTY
2248. HTZ
2249. HWA
2250. HWB
2251. HWC
2252. HWD
2253. HWE
2254. HWF
2255. HWI
2256. HWJ
2257. HWK
2258. HWL
2259. HWM
2260. HWN
2261. HWO
2262. HWP
2263. HWQ
2264. HWR
2265. HWT
2266. HWW
2267. HWX
2268. HXA
2269. HXB
2270. HXC
2271. HXD
2272. HXE
2273. HXG
2274. HXI
2275. HXJ
2276. HXK
2277. HXL
2278. HXN
2279. HXO
2280. HXP
2281. HXQ
2282. HXR
2283. HXS
2284. HXT
2285. HXW
2286. HXX
2287. HXY
2288. HXZ
2289. HYA
2290. HYB
2291. HYC
2292. HYD
2293. HYE
2294. HYF
2295. HYG
2296. HYH
2297. HYI
2298. HYJ
2299. HYK
2300. HYL
2301. HYO
2302. HYQ
2303. HYR
2304. HYS
2305. HYT
2306. HYW
2307. HYY
2308. HYZ
2309. HZA
2310. HZC
2311. HZD
2312. HZE
2313. HZF
2314. HZG
2315. HZH
2316. HZI
2317. HZJ
2318. HZL
2319. HZM
2320. HZN
2321. HZO
2322. HZP
2323. HZQ
2324. HZR
2325. HZS
2326. HZT
2327. HZX
2328. HZY
2329. HZZ
2330. IAA
2331. IAB
2332. IAC
2333. IAD
2334. IAE
Docket No. FDA-2017-N-6730
February 26, 2018
Page 22 of 50
2335. IAF
2336. IAL
2337. IAM
2338. IAT
2339. IAW
2340. IAY
2341. IAZ
2342. IBA
2343. IBB
2344. IBC
2345. IBD
2346. IBE
2347. IBF
2348. IBG
2349. IBJ
2350. IBK
2351. IBL
2352. IBM
2353. ICC
2354. ICD
2355. ICF
2356. ICG
2357. ICH
2358. ICI
2359. ICJ
2360. ICL
2361. ICM
2362. ICN
2363. ICO
2364. ICQ
2365. ICR
2366. ICS
2367. ICT
2368. ICX
2369. ICY
2370. ICZ
2371. IDA
2372. IDB
2373. IDC
2374. IDD
2375. IDE
2376. IDF
2377. IDL
2378. IDM
2379. IDN
2380. IDO
2381. IDP
2382. IDQ
2383. IDR
2384. IDS
2385. IDT
2386. IDW
2387. IDX
2388. IDY
2389. IDZ
2390. IEG
2391. IEH
2392. IEO
2393. IER
2394. IEX
2395. IEZ
2396. IFB
2397. IFF
2398. IFH
2399. IFI
2400. IFJ
2401. IFL
2402. IFN
2403. IFO
2404. IFP
2405. IFQ
2406. IFS
2407. IFT
2408. IFY
2409. IFZ
2410. IGB
2411. IGC
2412. IGD
2413. IGE
2414. IGF
2415. IGG
2416. IGK
2417. IGM
2418. IGN
2419. IHJ
2420. IJZ
2421. IKD
2422. IKE
2423. IKK
2424. IKN
2425. IKO
2426. IKP
2427. IKT
2428. IKW
2429. IKX
2430. IKY
2431. IKZ
2432. ILC
2433. ILD
2434. ILE
2435. ILG
2436. ILH
2437. ILI
2438. ILJ
2439. ILK
2440. ILM
2441. ILO
2442. ILP
2443. ILQ
2444. ILS
2445. ILT
2446. ILW
2447. ILX
2448. ILY
2449. ILZ
2450. IMA
2451. IMB
2452. IMC
2453. IMD
2454. IME
2455. IMF
2456. IMG
2457. IMI
2458. IMJ
2459. IMK
2460. IML
2461. IMM
2462. IMN
2463. IMO
2464. IMP
2465. IMQ
2466. IMR
2467. IMS
2468. IMW
2469. IMX
2470. IMY
2471. IMZ
2472. INA
Docket No. FDA-2017-N-6730
February 26, 2018
Page 23 of 50
2473. INB
2474. INC
2475. INE
2476. INF
2477. ING
2478. INI
2479. INK
2480. INM
2481. INN
2482. INO
2483. INP
2484. INQ
2485. INT
2486. INW
2487. INX
2488. INY
2489. IOA
2490. IOB
2491. IOD
2492. IOE
2493. IOG
2494. IOL
2495. ION
2496. IOQ
2497. IOR
2498. IOY
2499. IOZ
2500. IPF
2501. IPG
2502. IPL
2503. IPM
2504. IPO
2505. IPR
2506. IPS
2507. IPT
2508. IPW
2509. IPX
2510. IPY
2511. IQA
2512. IQB
2513. IQC
2514. IQE
2515. IQF
2516. IQG
2517. IQI
2518. IQJ
2519. IQK
2520. IQM
2521. IQO
2522. IQP
2523. IQQ
2524. IQW
2525. IQX
2526. IQZ
2527. IRA
2528. IRD
2529. IRE
2530. IRN
2531. IRO
2532. IRP
2533. IRQ
2534. IRR
2535. IRS
2536. IRT
2537. ISA
2538. ISB
2539. ISD
2540. ISH
2541. ISL
2542. ISM
2543. ISN
2544. ISP
2545. ISR
2546. ISS
2547. ISW
2548. ISY
2549. ISZ
2550. ITC
2551. ITG
2552. ITH
2553. ITI
2554. ITJ
2555. ITM
2556. ITN
2557. ITO
2558. ITQ
2559. ITS
2560. ITW
2561. ITX
2562. ITY
2563. ITZ
2564. IWA
2565. IWB
2566. IWD
2567. IWE
2568. IWF
2569. IWG
2570. IWH
2571. IWI
2572. IWJ
2573. IWK
2574. IWL
2575. IWM
2576. IWN
2577. IWO
2578. IWP
2579. IWQ
2580. IWR
2581. IWS
2582. IWT
2583. IWW
2584. IWX
2585. IWY
2586. IWZ
2587. IXA
2588. IXC
2589. IXD
2590. IXF
2591. IXG
2592. IXH
2593. IXI
2594. IXJ
2595. IXK
2596. IXL
2597. IXO
2598. IXQ
2599. IXR
2600. IXW
2601. IXX
2602. IXY
2603. IYB
2604. IYC
2605. IYD
2606. IYE
2607. IYG
2608. IYH
2609. IYI
2610. IYJ
Docket No. FDA-2017-N-6730
February 26, 2018
Page 24 of 50
2611. IYK
2612. IYL
2613. IYM
2614. IYN
2615. IYO
2616. IYP
2617. IYQ
2618. IYT
2619. IYW
2620. IYX
2621. IYY
2622. IYZ
2623. IZC
2624. IZD
2625. IZF
2626. IZG
2627. IZH
2628. IZI
2629. IZJ
2630. IZL
2631. IZO
2632. IZP
2633. IZQ
2634. IZS
2635. IZT
2636. IZW
2637. IZX
2638. IZZ
2639. JAA
2640. JAB
2641. JAC
2642. JAD
2643. JAE
2644. JAF
2645. JAG
2646. JAI
2647. JAK
2648. JAM
2649. JAN
2650. JAO
2651. JAQ
2652. JAR
2653. JAX
2654. JAY
2655. JAZ
2656. JBB
2657. JBD
2658. JBE
2659. JBF
2660. JBG
2661. JBH
2662. JBI
2663. JBJ
2664. JBK
2665. JBL
2666. JBM
2667. JBN
2668. JBO
2669. JBP
2670. JBQ
2671. JBR
2672. JBS
2673. JBT
2674. JBW
2675. JBX
2676. JBY
2677. JBZ
2678. JCA
2679. JCB
2680. JCC
2681. JCE
2682. JCF
2683. JCG
2684. JCH
2685. JCI
2686. JCJ
2687. JCM
2688. JCN
2689. JCO
2690. JCQ
2691. JCT
2692. JCW
2693. JCX
2694. JCY
2695. JDB
2696. JDC
2697. JDD
2698. JDG
2699. JDH
2700. JDI
2701. JDJ
2702. JDK
2703. JDL
2704. JDN
2705. JDO
2706. JDP
2707. JDQ
2708. JDR
2709. JDS
2710. JDT
2711. JDW
2712. JDX
2713. JDY
2714. JDZ
2715. JEA
2716. JEB
2717. JEC
2718. JED
2719. JEF
2720. JEG
2721. JEH
2722. JEI
2723. JEJ
2724. JEK
2725. JEL
2726. JEO
2727. JEP
2728. JEQ
2729. JER
2730. JES
2731. JET
2732. JEW
2733. JEX
2734. JEY
2735. JEZ
2736. JFA
2737. JFB
2738. JFC
2739. JFE
2740. JFH
2741. JFJ
2742. JFL
2743. JFM
2744. JFN
2745. JFO
2746. JFP
2747. JFQ
2748. JFR
Docket No. FDA-2017-N-6730
February 26, 2018
Page 25 of 50
2749. JFS
2750. JFT
2751. JFY
2752. JGC
2753. JGD
2754. JGE
2755. JGF
2756. JGG
2757. JGI
2758. JGJ
2759. JGK
2760. JGM
2761. JGP
2762. JGQ
2763. JGR
2764. JGS
2765. JGT
2766. JGW
2767. JGX
2768. JGY
2769. JGZ
2770. JHA
2771. JHC
2772. JHD
2773. JHE
2774. JHF
2775. JHG
2776. JHH
2777. JHI
2778. JHJ
2779. JHL
2780. JHM
2781. JHN
2782. JHO
2783. JHP
2784. JHQ
2785. JHR
2786. JHS
2787. JHT
2788. JHW
2789. JHX
2790. JHY
2791. JIA
2792. JIB
2793. JIC
2794. JID
2795. JIE
2796. JIF
2797. JIG
2798. JIH
2799. JII
2800. JIJ
2801. JIK
2802. JIL
2803. JIM
2804. JIN
2805. JIO
2806. JIP
2807. JIQ
2808. JIR
2809. JIS
2810. JIT
2811. JIW
2812. JIX
2813. JIY
2814. JIZ
2815. JJA
2816. JJB
2817. JJC
2818. JJE
2819. JJF
2820. JJG
2821. JJH
2822. JJI
2823. JJJ
2824. JJK
2825. JJL
2826. JJM
2827. JJN
2828. JJO
2829. JJP
2830. JJQ
2831. JJR
2832. JJS
2833. JJT
2834. JJW
2835. JJX
2836. JJY
2837. JKA
2838. JKB
2839. JKC
2840. JKD
2841. JKF
2842. JKG
2843. JKH
2844. JKJ
2845. JKL
2846. JKM
2847. JKP
2848. JKQ
2849. JKR
2850. JKS
2851. JKT
2852. JKW
2853. JKX
2854. JKY
2855. JKZ
2856. JLA
2857. JLB
2858. JLC
2859. JLD
2860. JLE
2861. JLF
2862. JLG
2863. JLH
2864. JLI
2865. JLJ
2866. JLK
2867. JLL
2868. JLM
2869. JLN
2870. JLO
2871. JLP
2872. JLQ
2873. JLR
2874. JLS
2875. JLT
2876. JLW
2877. JLX
2878. JLY
2879. JLZ
2880. JMA
2881. JMB
2882. JMC
2883. JMD
2884. JME
2885. JMF
2886. JMG
Docket No. FDA-2017-N-6730
February 26, 2018
Page 26 of 50
2887. JMH
2888. JMI
2889. JMJ
2890. JMK
2891. JMM
2892. JMN
2893. JMO
2894. JMQ
2895. JMR
2896. JMS
2897. JMT
2898. JMW
2899. JMX
2900. JMY
2901. JMZ
2902. JNA
2903. JNB
2904. JNC
2905. JND
2906. JNE
2907. JNF
2908. JNG
2909. JNJ
2910. JNK
2911. JNL
2912. JNM
2913. JNN
2914. JNO
2915. JNP
2916. JNQ
2917. JNS
2918. JNT
2919. JNW
2920. JNX
2921. JNY
2922. JNZ
2923. JOA
2924. JOB
2925. JOC
2926. JOD
2927. JOF
2928. JOH
2929. JOJ
2930. JOK
2931. JOL
2932. JOM
2933. JON
2934. JOO
2935. JOP
2936. JOQ
2937. JOR
2938. JOS
2939. JOT
2940. JOW
2941. JOX
2942. JOY
2943. JOZ
2944. JPA
2945. JPB
2946. JPC
2947. JPD
2948. JPE
2949. JPF
2950. JPH
2951. JPI
2952. JPJ
2953. JPK
2954. JPW
2955. JPZ
2956. JQA
2957. JQB
2958. JQC
2959. JQD
2960. JQE
2961. JQF
2962. JQG
2963. JQH
2964. JQI
2965. JQJ
2966. JQK
2967. JQL
2968. JQM
2969. JQN
2970. JQO
2971. JQP
2972. JQQ
2973. JQT
2974. JQW
2975. JQX
2976. JQY
2977. JQZ
2978. JRA
2979. JRB
2980. JRC
2981. JRE
2982. JRG
2983. JRI
2984. JRJ
2985. JRK
2986. JRL
2987. JRM
2988. JRO
2989. JRQ
2990. JRR
2991. JRS
2992. JRW
2993. JRY
2994. JRZ
2995. JSA
2996. JSB
2997. JSC
2998. JSD
2999. JSE
3000. JSF
3001. JSG
3002. JSH
3003. JSI
3004. JSJ
3005. JSK
3006. JSL
3007. JSM
3008. JSN
3009. JSO
3010. JSP
3011. JSQ
3012. JSR
3013. JSS
3014. JST
3015. JSW
3016. JSX
3017. JSY
3018. JSZ
3019. JTA
3020. JTB
3021. JTC
3022. JTL
3023. JTM
3024. JTN
Docket No. FDA-2017-N-6730
February 26, 2018
Page 27 of 50
3025. JTO
3026. JTQ
3027. JTR
3028. JTS
3029. JTT
3030. JTW
3031. JTX
3032. JTY
3033. JTZ
3034. JWH
3035. JWI
3036. JWJ
3037. JWK
3038. JWL
3039. JWM
3040. JWO
3041. JWR
3042. JWT
3043. JWW
3044. JWX
3045. JWY
3046. JWZ
3047. JXA
3048. JXB
3049. JXC
3050. JXE
3051. JXF
3052. JXG
3053. JXH
3054. JXI
3055. JXK
3056. JXL
3057. JXM
3058. JXN
3059. JXO
3060. JXQ
3061. JXR
3062. JXS
3063. JXT
3064. JXW
3065. JXX
3066. JXY
3067. JXZ
3068. JYA
3069. JYB
3070. JYC
3071. JYD
3072. JYE
3073. JYF
3074. JYG
3075. JYH
3076. JYI
3077. JYJ
3078. JYK
3079. JYL
3080. JYM
3081. JYN
3082. JYO
3083. JYP
3084. JYQ
3085. JYR
3086. JYS
3087. JYT
3088. JYW
3089. JYX
3090. JYY
3091. JYZ
3092. JZA
3093. JZB
3094. JZC
3095. JZD
3096. JZE
3097. JZF
3098. JZG
3099. JZH
3100. JZJ
3101. JZO
3102. JZP
3103. JZQ
3104. JZR
3105. JZS
3106. JZT
3107. JZW
3108. JZX
3109. JZY
3110. JZZ
3111. KAA
3112. KAB
3113. KAC
3114. KAD
3115. KAE
3116. KAG
3117. KAH
3118. KAI
3119. KAJ
3120. KAK
3121. KAL
3122. KAM
3123. KAN
3124. KAO
3125. KAP
3126. KAQ
3127. KAR
3128. KAS
3129. KAT
3130. KAW
3131. KAX
3132. KAY
3133. KAZ
3134. KBA
3135. KBB
3136. KBC
3137. KBD
3138. KBE
3139. KBF
3140. KBG
3141. KBH
3142. KBI
3143. KBJ
3144. KBK
3145. KBL
3146. KBM
3147. KBN
3148. KBO
3149. KBP
3150. KBQ
3151. KBR
3152. KBS
3153. KBT
3154. KBW
3155. KBX
3156. KBY
3157. KBZ
3158. KCA
3159. KCB
3160. KCC
3161. KCD
3162. KCE
Docket No. FDA-2017-N-6730
February 26, 2018
Page 28 of 50
3163. KCF
3164. KCG
3165. KCH
3166. KCI
3167. KCJ
3168. KCL
3169. KCM
3170. KCN
3171. KCO
3172. KCP
3173. KCQ
3174. KCR
3175. KCS
3176. KCT
3177. KCW
3178. KCX
3179. KCY
3180. KCZ
3181. KDA
3182. KDC
3183. KDD
3184. KDG
3185. KDH
3186. KDI
3187. KDJ
3188. KDK
3189. KDL
3190. KDM
3191. KDN
3192. KDO
3193. KDP
3194. KDQ
3195. KDT
3196. KDW
3197. KDX
3198. KDY
3199. KDZ
3200. KEA
3201. KEE
3202. KEF
3203. KEG
3204. KEH
3205. KEI
3206. KEJ
3207. KEL
3208. KEM
3209. KEO
3210. KEP
3211. KEQ
3212. KER
3213. KES
3214. KET
3215. KEW
3216. KEX
3217. KEY
3218. KFC
3219. KFD
3220. KFE
3221. KFF
3222. KFG
3223. KFH
3224. KFI
3225. KFJ
3226. KFK
3227. KFL
3228. KFM
3229. KFT
3230. KFW
3231. KFX
3232. KFZ
3233. KGB
3234. KGC
3235. KGD
3236. KGE
3237. KGF
3238. KGG
3239. KGH
3240. KGI
3241. KGK
3242. KGL
3243. KGM
3244. KGN
3245. KGO
3246. KGQ
3247. KGS
3248. KGT
3249. KGW
3250. KGX
3251. KGY
3252. KGZ
3253. KHA
3254. KHE
3255. KHF
3256. KHG
3257. KHH
3258. KHJ
3259. KHL
3260. KHM
3261. KHO
3262. KHP
3263. KHQ
3264. KHR
3265. KHS
3266. KHT
3267. KHW
3268. KHX
3269. KHY
3270. KIA
3271. KIC
3272. KID
3273. KIE
3274. KIF
3275. KIG
3276. KIH
3277. KII
3278. KIJ
3279. KIK
3280. KIL
3281. KIM
3282. KIN
3283. KIO
3284. KIP
3285. KIQ
3286. KIR
3287. KIS
3288. KIT
3289. KIW
3290. KIX
3291. KIY
3292. KIZ
3293. KJA
3294. KJB
3295. KJC
3296. KJD
3297. KJE
3298. KJF
3299. KJG
3300. KJH
Docket No. FDA-2017-N-6730
February 26, 2018
Page 29 of 50
3301. KJI
3302. KJJ
3303. KJK
3304. KJL
3305. KJM
3306. KJN
3307. KJO
3308. KJP
3309. KJQ
3310. KJR
3311. KJS
3312. KJT
3313. KJW
3314. KJX
3315. KJY
3316. KJZ
3317. KKA
3318. KKB
3319. KKC
3320. KKD
3321. KKE
3322. KKF
3323. KKG
3324. KKH
3325. KKI
3326. KKJ
3327. KKK
3328. KKL
3329. KKM
3330. KKO
3331. KKP
3332. KKQ
3333. KKR
3334. KKS
3335. KKT
3336. KKW
3337. KKX
3338. KKY
3339. KLA
3340. KLB
3341. KLC
3342. KLE
3343. KLH
3344. KLI
3345. KLJ
3346. KLK
3347. KLN
3348. KLO
3349. KLP
3350. KLQ
3351. KLR
3352. KLS
3353. KLT
3354. KLW
3355. KLX
3356. KLZ
3357. KMA
3358. KMB
3359. KMC
3360. KMD
3361. KME
3362. KMF
3363. KMG
3364. KMH
3365. KMI
3366. KMJ
3367. KMK
3368. KMN
3369. KMO
3370. KMS
3371. KMT
3372. KMW
3373. KMY
3374. KNA
3375. KNB
3376. KNC
3377. KND
3378. KNE
3379. KNF
3380. KNG
3381. KNH
3382. KNK
3383. KNL
3384. KNM
3385. KNN
3386. KNO
3387. KNP
3388. KNQ
3389. KNR
3390. KNS
3391. KNT
3392. KNW
3393. KNX
3394. KNY
3395. KNZ
3396. KOA
3397. KOB
3398. KOC
3399. KOD
3400. KOE
3401. KOH
3402. KOI
3403. KOJ
3404. KOK
3405. KOL
3406. KOM
3407. KON
3408. KOO
3409. KOP
3410. KOQ
3411. KOR
3412. KOS
3413. KOT
3414. KOX
3415. KOY
3416. KOZ
3417. KPA
3418. KPB
3419. KPD
3420. KPE
3421. KPF
3422. KPH
3423. KPI
3424. KPJ
3425. KPK
3426. KPL
3427. KPM
3428. KPN
3429. KPO
3430. KPP
3431. KPQ
3432. KPR
3433. KPS
3434. KPT
3435. KPW
3436. KPX
3437. KPY
3438. KPZ
Docket No. FDA-2017-N-6730
February 26, 2018
Page 30 of 50
3439. KQA
3440. KQC
3441. KQE
3442. KQF
3443. KQG
3444. KQH
3445. KQI
3446. KQJ
3447. KQL
3448. KQM
3449. KQN
3450. KQO
3451. KQP
3452. KQQ
3453. KQR
3454. KQS
3455. KQT
3456. KQW
3457. KQX
3458. KQZ
3459. KRA
3460. KRB
3461. KRC
3462. KRD
3463. KRE
3464. KRF
3465. KRG
3466. KRH
3467. KRI
3468. KRJ
3469. KRK
3470. KRL
3471. KRN
3472. KRO
3473. KRP
3474. KRQ
3475. KRR
3476. KRS
3477. KRX
3478. KRY
3479. KRZ
3480. KSA
3481. KSB
3482. KSD
3483. KSE
3484. KSF
3485. KSG
3486. KSH
3487. KSI
3488. KSJ
3489. KSK
3490. KSL
3491. KSM
3492. KSN
3493. KSO
3494. KSP
3495. KSQ
3496. KSR
3497. KSS
3498. KST
3499. KSW
3500. KSX
3501. KSY
3502. KSZ
3503. KTA
3504. KTB
3505. KTC
3506. KTD
3507. KTE
3508. KTF
3509. KTG
3510. KTH
3511. KTI
3512. KTJ
3513. KTK
3514. KTL
3515. KTM
3516. KTN
3517. KTO
3518. KTP
3519. KTQ
3520. KTR
3521. KTS
3522. KTT
3523. KTW
3524. KTX
3525. KTZ
3526. KWA
3527. KWB
3528. KWD
3529. KWE
3530. KWF
3531. KWG
3532. KWH
3533. KWI
3534. KWJ
3535. KWK
3536. KWL
3537. KWM
3538. KWN
3539. KWO
3540. KWP
3541. KWQ
3542. KWR
3543. KWS
3544. KWT
3545. KWW
3546. KWX
3547. KWY
3548. KWZ
3549. KXA
3550. KXB
3551. KXC
3552. KXD
3553. KXE
3554. KXF
3555. KXG
3556. KXH
3557. KXJ
3558. KXK
3559. KXM
3560. KXN
3561. KXO
3562. KXP
3563. KXQ
3564. KXR
3565. KXS
3566. KXT
3567. KXW
3568. KXX
3569. KXY
3570. KXZ
3571. KYA
3572. KYB
3573. KYD
3574. KYE
3575. KYF
3576. KYG
Docket No. FDA-2017-N-6730
February 26, 2018
Page 31 of 50
3577. KYH
3578. KYI
3579. KYJ
3580. KYK
3581. KYM
3582. KYN
3583. KYP
3584. KYQ
3585. KYR
3586. KYS
3587. KYT
3588. KYW
3589. KYX
3590. KYZ
3591. KZA
3592. KZB
3593. KZC
3594. KZD
3595. KZE
3596. KZF
3597. KZH
3598. KZI
3599. KZJ
3600. KZK
3601. KZL
3602. KZM
3603. KZN
3604. KZO
3605. KZP
3606. KZQ
3607. KZR
3608. KZS
3609. KZT
3610. KZW
3611. KZX
3612. KZY
3613. KZZ
3614. LAA
3615. LAB
3616. LAC
3617. LAD
3618. LAE
3619. LAF
3620. LAG
3621. LAH
3622. LAI
3623. LAJ
3624. LAK
3625. LAL
3626. LAM
3627. LAN
3628. LAO
3629. LAP
3630. LAR
3631. LAS
3632. LAT
3633. LAW
3634. LAX
3635. LAY
3636. LAZ
3637. LBA
3638. LBB
3639. LBC
3640. LBE
3641. LBG
3642. LBH
3643. LBI
3644. LBJ
3645. LBK
3646. LBL
3647. LBM
3648. LBN
3649. LBP
3650. LBR
3651. LBS
3652. LBT
3653. LBW
3654. LBX
3655. LBY
3656. LBZ
3657. LCA
3658. LCC
3659. LCD
3660. LCE
3661. LCG
3662. LCH
3663. LCI
3664. LCJ
3665. LCK
3666. LCL
3667. LCM
3668. LCN
3669. LCO
3670. LCP
3671. LCQ
3672. LCR
3673. LCS
3674. LCT
3675. LCW
3676. LCX
3677. LCY
3678. LCZ
3679. LDA
3680. LDB
3681. LDC
3682. LDD
3683. LDE
3684. LDF
3685. LDG
3686. LDH
3687. LDI
3688. LDJ
3689. LDK
3690. LDM
3691. LDN
3692. LDO
3693. LDP
3694. LDR
3695. LDS
3696. LDW
3697. LDX
3698. LDY
3699. LDZ
3700. LEA
3701. LEB
3702. LEC
3703. LED
3704. LEE
3705. LEF
3706. LEG
3707. LEH
3708. LEI
3709. LEJ
3710. LEK
3711. LEL
3712. LEM
3713. LEQ
3714. LER
Docket No. FDA-2017-N-6730
February 26, 2018
Page 32 of 50
3715. LES
3716. LET
3717. LEW
3718. LEY
3719. LEZ
3720. LFA
3721. LFB
3722. LFC
3723. LFD
3724. LFE
3725. LFF
3726. LFG
3727. LFH
3728. LFI
3729. LFJ
3730. LFK
3731. LFL
3732. LFM
3733. LFN
3734. LFO
3735. LFP
3736. LFQ
3737. LFR
3738. LFS
3739. LFT
3740. LFW
3741. LFX
3742. LFY
3743. LFZ
3744. LGA
3745. LGB
3746. LGC
3747. LGD
3748. LGE
3749. LGF
3750. LGG
3751. LGH
3752. LGI
3753. LGJ
3754. LGL
3755. LGM
3756. LGN
3757. LGO
3758. LGP
3759. LGQ
3760. LGR
3761. LGS
3762. LGW
3763. LGX
3764. LGY
3765. LGZ
3766. LHB
3767. LHC
3768. LHD
3769. LHE
3770. LHF
3771. LHG
3772. LHI
3773. LHJ
3774. LHK
3775. LHL
3776. LHM
3777. LHN
3778. LHO
3779. LHP
3780. LHQ
3781. LHR
3782. LHT
3783. LHW
3784. LHX
3785. LHY
3786. LHZ
3787. LIA
3788. LIB
3789. LIC
3790. LIE
3791. LIF
3792. LIG
3793. LIH
3794. LII
3795. LIJ
3796. LIL
3797. LIM
3798. LIN
3799. LIO
3800. LIP
3801. LIQ
3802. LIR
3803. LIT
3804. LIX
3805. LIY
3806. LIZ
3807. LJB
3808. LJC
3809. LJD
3810. LJE
3811. LJF
3812. LJG
3813. LJH
3814. LJJ
3815. LJK
3816. LJL
3817. LJM
3818. LJN
3819. LJO
3820. LJP
3821. LJS
3822. LJT
3823. LJW
3824. LJX
3825. LJY
3826. LJZ
3827. LKA
3828. LKB
3829. LKC
3830. LKD
3831. LKF
3832. LKG
3833. LKH
3834. LKI
3835. LKJ
3836. LKK
3837. LKL
3838. LKM
3839. LKN
3840. LKO
3841. LKP
3842. LKQ
3843. LKS
3844. LKT
3845. LKV
3846. LKW
3847. LKX
3848. LKY
3849. LKZ
3850. LLA
3851. LLB
3852. LLC
Docket No. FDA-2017-N-6730
February 26, 2018
Page 33 of 50
3853. LLD
3854. LLE
3855. LLF
3856. LLG
3857. LLH
3858. LLI
3859. LLK
3860. LLL
3861. LLM
3862. LLN
3863. LLO
3864. LLQ
3865. LLT
3866. LLW
3867. LLX
3868. LLY
3869. LLZ
3870. LMA
3871. LMB
3872. LMC
3873. LMD
3874. LME
3875. LMF
3876. LMG
3877. LMH
3878. LMI
3879. LML
3880. LMN
3881. LMQ
3882. LMS
3883. LMW
3884. LMY
3885. LMZ
3886. LNB
3887. LNC
3888. LNH
3889. LNI
3890. LNJ
3891. LNK
3892. LNL
3893. LNM
3894. LNQ
3895. LNR
3896. LNS
3897. LNW
3898. LNX
3899. LNY
3900. LNZ
3901. LOA
3902. LOB
3903. LOC
3904. LOD
3905. LOE
3906. LOF
3907. LOG
3908. LOH
3909. LOI
3910. LOJ
3911. LOK
3912. LOL
3913. LOM
3914. LON
3915. LOO
3916. LOP
3917. LOQ
3918. LOT
3919. LOX
3920. LOZ
3921. LPA
3922. LPB
3923. LPC
3924. LPF
3925. LPG
3926. LPH
3927. LPI
3928. LPJ
3929. LPK
3930. LPL
3931. LPM
3932. LPN
3933. LPO
3934. LPP
3935. LPQ
3936. LPS
3937. LPT
3938. LPW
3939. LPX
3940. LPZ
3941. LQA
3942. LQB
3943. LQC
3944. LQD
3945. LQE
3946. LQF
3947. LQG
3948. LQH
3949. LQI
3950. LQJ
3951. LQK
3952. LQL
3953. LQM
3954. LQN
3955. LQO
3956. LQP
3957. LQQ
3958. LQR
3959. LQS
3960. LQW
3961. LQX
3962. LQY
3963. LQZ
3964. LRA
3965. LRB
3966. LRC
3967. LRD
3968. LRE
3969. LRF
3970. LRG
3971. LRH
3972. LRI
3973. LRJ
3974. LRK
3975. LRL
3976. LRM
3977. LRN
3978. LRO
3979. LRP
3980. LRQ
3981. LRR
3982. LRS
3983. LRT
3984. LRW
3985. LRX
3986. LRY
3987. LRZ
3988. LSA
3989. LSB
3990. LSC
Docket No. FDA-2017-N-6730
February 26, 2018
Page 34 of 50
3991. LSD
3992. LSE
3993. LSF
3994. LSG
3995. LSH
3996. LSI
3997. LSJ
3998. LSK
3999. LSL
4000. LSM
4001. LSN
4002. LSO
4003. LSQ
4004. LSR
4005. LST
4006. LSW
4007. LSX
4008. LSY
4009. LSZ
4010. LTA
4011. LTB
4012. LTC
4013. LTD
4014. LTF
4015. LTG
4016. LTI
4017. LTJ
4018. LTK
4019. LTO
4020. LTQ
4021. LTS
4022. LTT
4023. LTW
4024. LTX
4025. LTY
4026. LTZ
4027. LWA
4028. LWB
4029. LWE
4030. LWF
4031. LWG
4032. LWH
4033. LWI
4034. LWJ
4035. LWK
4036. LWL
4037. LWM
4038. LWO
4039. LWP
4040. LWQ
4041. LWR
4042. LWS
4043. LWT
4044. LWW
4045. LWX
4046. LWZ
4047. LXA
4048. LXB
4049. LXC
4050. LXE
4051. LXF
4052. LXG
4053. LXH
4054. LXI
4055. LXJ
4056. LXK
4057. LXM
4058. LXN
4059. LXO
4060. LXP
4061. LXQ
4062. LXR
4063. LXS
4064. LXT
4065. LXV
4066. LXW
4067. LXY
4068. LXZ
4069. LYA
4070. LYB
4071. LYC
4072. LYE
4073. LYF
4074. LYG
4075. LYH
4076. LYI
4077. LYJ
4078. LYK
4079. LYL
4080. LYM
4081. LYN
4082. LYP
4083. LYQ
4084. LYR
4085. LYS
4086. LYT
4087. LYU
4088. LYV
4089. LYX
4090. LYY
4091. LYZ
4092. LZA
4093. LZB
4094. LZC
4095. LZD
4096. LZE
4097. LZF
4098. LZG
4099. LZH
4100. LZI
4101. LZJ
4102. LZK
4103. LZL
4104. LZM
4105. LZN
4106. LZO
4107. LZP
4108. LZQ
4109. LZR
4110. LZS
4111. LZU
4112. LZV
4113. LZW
4114. LZY
4115. MAA
4116. MAB
4117. MAC
4118. MAD
4119. MAE
4120. MAF
4121. MAH
4122. MAI
4123. MAJ
4124. MAL
4125. MAM
4126. MAN
4127. MAO
4128. MAQ
Docket No. FDA-2017-N-6730
February 26, 2018
Page 35 of 50
4129. MAR
4130. MAU
4131. MAV
4132. MAW
4133. MAX
4134. MAY
4135. MBB
4136. MBD
4137. MBF
4138. MBH
4139. MBI
4140. MBJ
4141. MBL
4142. MBP
4143. MBQ
4144. MBS
4145. MBT
4146. MBU
4147. MBV
4148. MCA
4149. MCB
4150. MCC
4151. MCD
4152. MCE
4153. MCF
4154. MCG
4155. MCH
4156. MCI
4157. MCJ
4158. MCK
4159. MCL
4160. MCM
4161. MCN
4162. MCP
4163. MCS
4164. MCT
4165. MCU
4166. MCV
4167. MCW
4168. MCX
4169. MCY
4170. MCZ
4171. MDA
4172. MDB
4173. MDC
4174. MDD
4175. MDE
4176. MDF
4177. MDG
4178. MDI
4179. MDJ
4180. MDK
4181. MDL
4182. MDM
4183. MDP
4184. MDR
4185. MDS
4186. MDT
4187. MDU
4188. MDZ
4189. MEA
4190. MEB
4191. MEC
4192. MED
4193. MEF
4194. MEG
4195. MEH
4196. MEQ
4197. MER
4198. MES
4199. MFA
4200. MFD
4201. MFE
4202. MFJ
4203. MFK
4204. MFR
4205. MFX
4206. MFY
4207. MGA
4208. MGB
4209. MGI
4210. MGM
4211. MGO
4212. MGP
4213. MGQ
4214. MGR
4215. MGS
4216. MGU
4217. MGV
4218. MGX
4219. MGZ
4220. MHC
4221. MHD
4222. MHE
4223. MHI
4224. MHJ
4225. MHR
4226. MHW
4227. MHX
4228. MHY
4229. MHZ
4230. MIA
4231. MIB
4232. MIC
4233. MID
4234. MIE
4235. MIF
4236. MIG
4237. MIH
4238. MIJ
4239. MIK
4240. MIP
4241. MIR
4242. MIU
4243. MIV
4244. MIW
4245. MIX
4246. MIY
4247. MIZ
4248. MJA
4249. MJB
4250. MJC
4251. MJD
4252. MJE
4253. MJF
4254. MJG
4255. MJH
4256. MJI
4257. MJJ
4258. MJK
4259. MJL
4260. MJM
4261. MJN
4262. MJO
4263. MJP
4264. MJS
4265. MJT
4266. MJV
Docket No. FDA-2017-N-6730
February 26, 2018
Page 36 of 50
4267. MJW
4268. MJX
4269. MJY
4270. MJZ
4271. MKA
4272. MKB
4273. MKD
4274. MKJ
4275. MKN
4276. MKO
4277. MKQ
4278. MKT
4279. MKU
4280. MKW
4281. MKY
4282. MKZ
4283. MLA
4284. MLC
4285. MLD
4286. MLE
4287. MLH
4288. MLK
4289. MLL
4290. MLM
4291. MLN
4292. MLO
4293. MLP
4294. MLQ
4295. MLR
4296. MLS
4297. MLT
4298. MLV
4299. MLW
4300. MLX
4301. MLY
4302. MLZ
4303. MMA
4304. MMC
4305. MMD
4306. MMF
4307. MMH
4308. MMI
4309. MMK
4310. MML
4311. MMO
4312. MMP
4313. MMQ
4314. MMS
4315. MMT
4316. MMU
4317. MMW
4318. MMX
4319. MMY
4320. MMZ
4321. MNA
4322. MNB
4323. MND
4324. MNE
4325. MNF
4326. MNG
4327. MNH
4328. MNI
4329. MNJ
4330. MNK
4331. MNL
4332. MNM
4333. MNO
4334. MNQ
4335. MNR
4336. MNS
4337. MNT
4338. MNU
4339. MNV
4340. MNW
4341. MOA
4342. MOB
4343. MOC
4344. MOD
4345. MOE
4346. MOF
4347. MOH
4348. MOI
4349. MOJ
4350. MOK
4351. MOL
4352. MOM
4353. MON
4354. MOO
4355. MOP
4356. MOQ
4357. MOS
4358. MOT
4359. MOU
4360. MOV
4361. MOX
4362. MOY
4363. MOZ
4364. MPA
4365. MPB
4366. MPC
4367. MPD
4368. MPE
4369. MPG
4370. MPI
4371. MPJ
4372. MPK
4373. MPL
4374. MPN
4375. MPO
4376. MPQ
4377. MPR
4378. MPT
4379. MPU
4380. MPV
4381. MPW
4382. MQA
4383. MQB
4384. MQC
4385. MQE
4386. MQF
4387. MQG
4388. MQH
4389. MQI
4390. MQJ
4391. MQK
4392. MQL
4393. MQM
4394. MQN
4395. MQO
4396. MQP
4397. MQR
4398. MQS
4399. MQT
4400. MQU
4401. MQV
4402. MQW
4403. MQX
4404. MQZ
Docket No. FDA-2017-N-6730
February 26, 2018
Page 37 of 50
4405. MRA
4406. MRB
4407. MRC
4408. MRD
4409. MRE
4410. MRF
4411. MRG
4412. MRH
4413. MRI
4414. MRJ
4415. MRK
4416. MRL
4417. MRM
4418. MRN
4419. MRO
4420. MRP
4421. MRQ
4422. MRR
4423. MRS
4424. MRU
4425. MRV
4426. MRW
4427. MRX
4428. MRY
4429. MRZ
4430. MSA
4431. MSB
4432. MSC
4433. MSD
4434. MSE
4435. MSF
4436. MSG
4437. MSH
4438. MSI
4439. MSJ
4440. MSK
4441. MSL
4442. MSM
4443. MSQ
4444. MSR
4445. MSS
4446. MST
4447. MSV
4448. MSW
4449. MSX
4450. MSY
4451. MSZ
4452. MTA
4453. MTC
4454. MTD
4455. MTE
4456. MTF
4457. MTG
4458. MTH
4459. MTI
4460. MTJ
4461. MTK
4462. MTL
4463. MTN
4464. MTO
4465. MTP
4466. MTQ
4467. MTR
4468. MTS
4469. MTV
4470. MTW
4471. MTX
4472. MTZ
4473. MUA
4474. MUD
4475. MUE
4476. MUH
4477. MUI
4478. MUJ
4479. MUK
4480. MUL
4481. MUM
4482. MUQ
4483. MUR
4484. MUS
4485. MUT
4486. MUU
4487. MUW
4488. MUZ
4489. MVA
4490. MVC
4491. MVD
4492. MVE
4493. MVF
4494. MVG
4495. MVH
4496. MVJ
4497. MVK
4498. MVL
4499. MVM
4500. MVN
4501. MVO
4502. MVR
4503. MVS
4504. MVU
4505. MVV
4506. MVW
4507. MVX
4508. MVY
4509. MVZ
4510. MWA
4511. MWB
4512. MWD
4513. MWH
4514. MWI
4515. MWJ
4516. MWL
4517. MWM
4518. MWO
4519. MWP
4520. MWQ
4521. MWS
4522. MWW
4523. MWY
4524. MWZ
4525. MXA
4526. MXB
4527. MXC
4528. MXD
4529. MXE
4530. MXF
4531. MXG
4532. MXJ
4533. MXK
4534. MXM
4535. MXO
4536. MXP
4537. MXQ
4538. MXT
4539. MXW
4540. MXY
4541. MXZ
4542. MYA
Docket No. FDA-2017-N-6730
February 26, 2018
Page 38 of 50
4543. MYB
4544. MYC
4545. MYD
4546. MYE
4547. MYF
4548. MYH
4549. MYI
4550. MYJ
4551. MYK
4552. MYL
4553. MYM
4554. MYN
4555. MYP
4556. MYQ
4557. MYR
4558. MYS
4559. MYT
4560. MYU
4561. MYW
4562. MYX
4563. MYY
4564. MYZ
4565. MZA
4566. MZC
4567. MZD
4568. MZE
4569. MZF
4570. MZG
4571. MZH
4572. MZI
4573. MZJ
4574. MZK
4575. MZL
4576. MZM
4577. MZO
4578. MZP
4579. MZQ
4580. MZR
4581. MZT
4582. MZU
4583. MZV
4584. MZW
4585. MZY
4586. NAA
4587. NAB
4588. NAC
4589. NAD
4590. NAE
4591. NAF
4592. NAH
4593. NAI
4594. NAJ
4595. NAK
4596. NAL
4597. NAM
4598. NAN
4599. NAO
4600. NAP
4601. NAQ
4602. NAS
4603. NAV
4604. NAW
4605. NAY
4606. NAZ
4607. NBC
4608. NBE
4609. NBF
4610. NBG
4611. NBH
4612. NBK
4613. NBL
4614. NBN
4615. NBO
4616. NBS
4617. NBT
4618. NBV
4619. NBW
4620. NBY
4621. NBZ
4622. NCA
4623. NCD
4624. NCE
4625. NCF
4626. NCG
4627. NCJ
4628. NCK
4629. NCL
4630. NCO
4631. NCP
4632. NCR
4633. NCS
4634. NCT
4635. NCV
4636. NCW
4637. NCX
4638. NCZ
4639. NDA
4640. NDC
4641. NDD
4642. NDE
4643. NDF
4644. NDG
4645. NDH
4646. NDI
4647. NDJ
4648. NDK
4649. NDL
4650. NDM
4651. NDN
4652. NDP
4653. NDQ
4654. NDR
4655. NDS
4656. NDV
4657. NDW
4658. NDY
4659. NDZ
4660. NEA
4661. NEC
4662. NEG
4663. NEH
4664. NEI
4665. NEJ
4666. NEK
4667. NEO
4668. NEP
4669. NEQ
4670. NEU
4671. NEW
4672. NEY
4673. NEZ
4674. NFA
4675. NFB
4676. NFD
4677. NFE
4678. NFF
4679. NFG
4680. NFH
Docket No. FDA-2017-N-6730
February 26, 2018
Page 39 of 50
4681. NFI
4682. NFJ
4683. NFK
4684. NFM
4685. NFO
4686. NFP
4687. NFQ
4688. NFR
4689. NFS
4690. NFT
4691. NFV
4692. NFW
4693. NFX
4694. NFY
4695. NFZ
4696. NGA
4697. NGB
4698. NGD
4699. NGE
4700. NGG
4701. NGI
4702. NGJ
4703. NGK
4704. NGL
4705. NGM
4706. NGO
4707. NGR
4708. NGS
4709. NGT
4710. NGU
4711. NGV
4712. NGX
4713. NGY
4714. NGZ
4715. NHA
4716. NHB
4717. NHC
4718. NHF
4719. NHG
4720. NHH
4721. NHI
4722. NHJ
4723. NHK
4724. NHL
4725. NHM
4726. NHN
4727. NHO
4728. NHP
4729. NHQ
4730. NHS
4731. NHT
4732. NHV
4733. NHW
4734. NHX
4735. NHY
4736. NHZ
4737. NIA
4738. NIC
4739. NID
4740. NIE
4741. NIF
4742. NIG
4743. NIH
4744. NII
4745. NIJ
4746. NIK
4747. NIM
4748. NIN
4749. NIO
4750. NIP
4751. NIQ
4752. NIU
4753. NIV
4754. NIX
4755. NIY
4756. NIZ
4757. NJA
4758. NJB
4759. NJC
4760. NJD
4761. NJE
4762. NJF
4763. NJG
4764. NJH
4765. NJJ
4766. NJL
4767. NJM
4768. NJN
4769. NJO
4770. NJR
4771. NJT
4772. NJU
4773. NJV
4774. NJW
4775. NJZ
4776. NKA
4777. NKB
4778. NKC
4779. NKE
4780. NKF
4781. NKG
4782. NKI
4783. NKJ
4784. NKK
4785. NKL
4786. NKM
4787. NKN
4788. NKO
4789. NKP
4790. NKQ
4791. NKR
4792. NKS
4793. NKT
4794. NKU
4795. NKW
4796. NKX
4797. NKY
4798. NKZ
4799. NLA
4800. NLB
4801. NLC
4802. NLD
4803. NLE
4804. NLF
4805. NLG
4806. NLH
4807. NLI
4808. NLJ
4809. NLK
4810. NLL
4811. NLM
4812. NLN
4813. NLO
4814. NLP
4815. NLQ
4816. NLR
4817. NLS
4818. NLT
Docket No. FDA-2017-N-6730
February 26, 2018
Page 40 of 50
4819. NLU
4820. NLV
4821. NLW
4822. NLX
4823. NLY
4824. NLZ
4825. NMA
4826. NMB
4827. NMC
4828. NMD
4829. NME
4830. NMF
4831. NMG
4832. NMH
4833. NMI
4834. NMJ
4835. NMK
4836. NML
4837. NMM
4838. NMN
4839. NMP
4840. NMR
4841. NMT
4842. NMU
4843. NMW
4844. NMX
4845. NMY
4846. NNA
4847. NNB
4848. NNC
4849. NNE
4850. NNG
4851. NNH
4852. NNI
4853. NNJ
4854. NNK
4855. NNL
4856. NNN
4857. NNO
4858. NNP
4859. NNQ
4860. NNR
4861. NNS
4862. NNT
4863. NNU
4864. NNV
4865. NNW
4866. NNX
4867. NNY
4868. NNZ
4869. NOA
4870. NOB
4871. NOC
4872. NOD
4873. NOE
4874. NOF
4875. NOG
4876. NOH
4877. NOI
4878. NOJ
4879. NOK
4880. NOM
4881. NON
4882. NOO
4883. NOP
4884. NOT
4885. NOU
4886. NOV
4887. NOX
4888. NOZ
4889. NPB
4890. NPE
4891. NPF
4892. NPH
4893. NPJ
4894. NPK
4895. NPL
4896. NPM
4897. NPO
4898. NPP
4899. NPQ
4900. NPR
4901. NPT
4902. NPU
4903. NPV
4904. NPZ
4905. NQA
4906. NQB
4907. NQC
4908. NQD
4909. NQE
4910. NQF
4911. NQG
4912. NQH
4913. NQI
4914. NQJ
4915. NQK
4916. NQL
4917. NQM
4918. NQN
4919. NQO
4920. NQP
4921. NQQ
4922. NQR
4923. NQS
4924. NQT
4925. NQU
4926. NQV
4927. NQW
4928. NQX
4929. NQY
4930. NQZ
4931. NRA
4932. NRB
4933. NRC
4934. NRD
4935. NRF
4936. NRH
4937. NRI
4938. NRJ
4939. NRK
4940. NRL
4941. NRN
4942. NRP
4943. NRQ
4944. NRS
4945. NRU
4946. NRV
4947. NRW
4948. NRX
4949. NRY
4950. NRZ
4951. NSA
4952. NSB
4953. NSC
4954. NSD
4955. NSF
4956. NSI
Docket No. FDA-2017-N-6730
February 26, 2018
Page 41 of 50
4957. NSJ
4958. NSK
4959. NSL
4960. NSM
4961. NSN
4962. NSO
4963. NSP
4964. NSQ
4965. NSR
4966. NSS
4967. NST
4968. NSU
4969. NSX
4970. NTB
4971. NTC
4972. NTE
4973. NTG
4974. NTH
4975. NTI
4976. NTK
4977. NTM
4978. NTN
4979. NTO
4980. NTR
4981. NTU
4982. NTV
4983. NTW
4984. NTX
4985. NTY
4986. NTZ
4987. NUA
4988. NUB
4989. NUC
4990. NUD
4991. NUF
4992. NUH
4993. NUI
4994. NUJ
4995. NUK
4996. NUL
4997. NUM
4998. NUN
4999. NUP
5000. NUQ
5001. NUR
5002. NUU
5003. NUV
5004. NUW
5005. NUX
5006. NVA
5007. NVB
5008. NVC
5009. NVE
5010. NVG
5011. NVH
5012. NVI
5013. NVJ
5014. NVK
5015. NVM
5016. NVN
5017. NVO
5018. NVP
5019. NVQ
5020. NVR
5021. NVT
5022. NVV
5023. NVY
5024. NVZ
5025. NWA
5026. NWB
5027. NWE
5028. NWF
5029. NWG
5030. NWI
5031. NWJ
5032. NWM
5033. NWN
5034. NWO
5035. NWP
5036. NWQ
5037. NWR
5038. NWS
5039. NWT
5040. NWU
5041. NWV
5042. NWW
5043. NWX
5044. NWY
5045. NWZ
5046. NXA
5047. NXB
5048. NXC
5049. NXD
5050. NXE
5051. NXF
5052. NXG
5053. NXH
5054. NXJ
5055. NXM
5056. NXO
5057. NXQ
5058. NXR
5059. NXT
5060. NXV
5061. NXX
5062. NXZ
5063. NYC
5064. NYD
5065. NYE
5066. NYF
5067. NYG
5068. NYH
5069. NYI
5070. NYK
5071. NYL
5072. NYN
5073. NYO
5074. NYQ
5075. NYS
5076. NYT
5077. NYU
5078. NYV
5079. NYW
5080. NYX
5081. NYY
5082. NYZ
5083. NZA
5084. NZB
5085. NZC
5086. NZD
5087. NZE
5088. NZF
5089. NZG
5090. NZH
5091. NZJ
5092. NZK
5093. NZP
5094. NZS
Docket No. FDA-2017-N-6730
February 26, 2018
Page 42 of 50
5095. NZT
5096. NZU
5097. NZW
5098. NZX
5099. NZY
5100. OAA
5101. OAB
5102. OAC
5103. OAD
5104. OAE
5105. OAF
5106. OAH
5107. OAI
5108. OAJ
5109. OAL
5110. OAM
5111. OAN
5112. OAO
5113. OAP
5114. OAQ
5115. OAR
5116. OAS
5117. OAT
5118. OAU
5119. OAV
5120. OAW
5121. OAX
5122. OAY
5123. OAZ
5124. OBA
5125. OBB
5126. OBC
5127. OBD
5128. OBE
5129. OBF
5130. OBH
5131. OBI
5132. OBJ
5133. OBK
5134. OBL
5135. OBM
5136. OBN
5137. OBO
5138. OBP
5139. OBR
5140. OBT
5141. OBV
5142. OBW
5143. OBY
5144. OBZ
5145. OCB
5146. OCC
5147. OCE
5148. OCF
5149. OCG
5150. OCH
5151. OCI
5152. OCJ
5153. OCK
5154. OCL
5155. OCM
5156. OCN
5157. OCO
5158. OCQ
5159. OCR
5160. OCS
5161. OCT
5162. OCU
5163. OCV
5164. OCW
5165. OCX
5166. OCY
5167. OCZ
5168. ODA
5169. ODB
5170. ODC
5171. ODD
5172. ODE
5173. ODF
5174. ODG
5175. ODH
5176. ODI
5177. ODK
5178. ODN
5179. ODP
5180. ODR
5181. ODS
5182. ODT
5183. ODU
5184. ODV
5185. ODW
5186. ODX
5187. ODY
5188. OEA
5189. OEB
5190. OED
5191. OEE
5192. OEG
5193. OEH
5194. OEI
5195. OEJ
5196. OEK
5197. OEL
5198. OEM
5199. OEO
5200. OEP
5201. OEQ
5202. OER
5203. OES
5204. OET
5205. OEU
5206. OEV
5207. OEW
5208. OEX
5209. OEY
5210. OEZ
5211. OFA
5212. OFB
5213. OFC
5214. OFD
5215. OFE
5216. OFF
5217. OFG
5218. OFH
5219. OFI
5220. OFJ
5221. OFK
5222. OFL
5223. OFM
5224. OFN
5225. OFO
5226. OFP
5227. OFQ
5228. OFR
5229. OFS
5230. OFT
5231. OFU
5232. OFV
Docket No. FDA-2017-N-6730
February 26, 2018
Page 43 of 50
5233. OFW
5234. OFX
5235. OFY
5236. OFZ
5237. OGA
5238. OGB
5239. OGC
5240. OGD
5241. OGE
5242. OGF
5243. OGG
5244. OGH
5245. OGI
5246. OGJ
5247. OGK
5248. OGL
5249. OGO
5250. OGP
5251. OGQ
5252. OGR
5253. OGS
5254. OGT
5255. OGU
5256. OGV
5257. OGW
5258. OGZ
5259. OHA
5260. OHC
5261. OHD
5262. OHE
5263. OHF
5264. OHG
5265. OHH
5266. OHI
5267. OHL
5268. OHM
5269. OHO
5270. OHP
5271. OHQ
5272. OHR
5273. OHS
5274. OHT
5275. OHV
5276. OHW
5277. OHX
5278. OHY
5279. OHZ
5280. OIA
5281. OIB
5282. OIC
5283. OID
5284. OIE
5285. OIF
5286. OIG
5287. OIH
5288. OII
5289. OIJ
5290. OIK
5291. OIL
5292. OIM
5293. OIN
5294. OIO
5295. OIP
5296. OIR
5297. OIS
5298. OIU
5299. OIV
5300. OIW
5301. OIY
5302. OIZ
5303. OJA
5304. OJB
5305. OJE
5306. OJF
5307. OJG
5308. OJH
5309. OJI
5310. OJJ
5311. OJK
5312. OJL
5313. OJM
5314. OJN
5315. OJO
5316. OJP
5317. OJQ
5318. OJR
5319. OJS
5320. OJT
5321. OJU
5322. OJV
5323. OJW
5324. OJX
5325. OJZ
5326. OKC
5327. OKD
5328. OKE
5329. OKF
5330. OKG
5331. OKH
5332. OKI
5333. OKJ
5334. OKL
5335. OKM
5336. OKN
5337. OKO
5338. OKP
5339. OKR
5340. OKS
5341. OKU
5342. OKV
5343. OKW
5344. OKX
5345. OKY
5346. OKZ
5347. OLC
5348. OLD
5349. OLF
5350. OLH
5351. OLI
5352. OLL
5353. OLM
5354. OLO
5355. OLP
5356. OLQ
5357. OLR
5358. OLS
5359. OLT
5360. OLU
5361. OLV
5362. OLW
5363. OLX
5364. OLY
5365. OLZ
5366. OMA
5367. OMB
5368. OMC
5369. OMD
5370. OME
Docket No. FDA-2017-N-6730
February 26, 2018
Page 44 of 50
5371. OMF
5372. OMG
5373. OMH
5374. OMI
5375. OMJ
5376. OMM
5377. OMN
5378. OMP
5379. OMR
5380. OMS
5381. OMT
5382. OMV
5383. OMW
5384. OMX
5385. OMZ
5386. ONA
5387. ONB
5388. OND
5389. ONE
5390. ONF
5391. ONG
5392. ONJ
5393. ONK
5394. ONL
5395. ONM
5396. ONN
5397. ONO
5398. ONQ
5399. ONT
5400. ONU
5401. ONW
5402. ONX
5403. ONZ
5404. OOA
5405. OOD
5406. OOE
5407. OOF
5408. OOG
5409. OOI
5410. OOK
5411. OOL
5412. OOU
5413. OOW
5414. OOX
5415. OOY
5416. OPA
5417. OPC
5418. OPH
5419. OPI
5420. OPJ
5421. OPL
5422. OPM
5423. OPN
5424. OPP
5425. OPT
5426. OPU
5427. OPX
5428. OPY
5429. OQG
5430. OQH
5431. OQI
5432. OQL
5433. OQO
5434. OQQ
5435. OQS
5436. OQT
5437. OQU
5438. OQW
5439. OQX
5440. OQY
5441. OQZ
5442. ORA
5443. ORC
5444. ORD
5445. ORE
5446. ORG
5447. ORH
5448. ORI
5449. ORK
5450. ORL
5451. ORQ
5452. ORR
5453. ORT
5454. ORW
5455. ORY
5456. ORZ
5457. OSD
5458. OSE
5459. OSF
5460. OSG
5461. OSH
5462. OSI
5463. OSK
5464. OSL
5465. OSM
5466. OSN
5467. OSP
5468. OSR
5469. OSS
5470. OSU
5471. OSV
5472. OSX
5473. OSZ
5474. OTA
5475. OTD
5476. OTE
5477. OTF
5478. OTG
5479. OTJ
5480. OTK
5481. OTM
5482. OTN
5483. OTO
5484. OTP
5485. OTQ
5486. OTR
5487. OTT
5488. OTU
5489. OTV
5490. OTW
5491. OTX
5492. OTZ
5493. OUB
5494. OUC
5495. OUE
5496. OUF
5497. OUG
5498. OUH
5499. OUJ
5500. OUK
5501. OUL
5502. OUM
5503. OUO
5504. OUP
5505. OUR
5506. OUS
5507. OUT
5508. OUU
Docket No. FDA-2017-N-6730
February 26, 2018
Page 45 of 50
5509. OUW
5510. OUY
5511. OUZ
5512. OVA
5513. OVB
5514. OVC
5515. OVD
5516. OVE
5517. OVF
5518. OVG
5519. OVJ
5520. OVK
5521. OVL
5522. OVN
5523. OVO
5524. OVP
5525. OVQ
5526. OVR
5527. OVX
5528. OVY
5529. OVZ
5530. OWB
5531. OWD
5532. OWE
5533. OWF
5534. OWI
5535. OWK
5536. OWL
5537. OWM
5538. OWN
5539. OWO
5540. OWP
5541. OWQ
5542. OWR
5543. OWS
5544. OWT
5545. OWU
5546. OWV
5547. OWW
5548. OWX
5549. OWY
5550. OWZ
5551. OXA
5552. OXB
5553. OXC
5554. OXD
5555. OXE
5556. OXF
5557. OXG
5558. OXH
5559. OXI
5560. OXJ
5561. OXK
5562. OXL
5563. OXM
5564. OXN
5565. OXO
5566. OXP
5567. OXQ
5568. OXR
5569. OXT
5570. OXW
5571. OXZ
5572. OYA
5573. OYB
5574. OYC
5575. OYD
5576. OYE
5577. OYG
5578. OYH
5579. OYI
5580. OYJ
5581. OYK
5582. OYL
5583. OYM
5584. OYO
5585. OYP
5586. OYR
5587. OYS
5588. OYT
5589. OYU
5590. OYV
5591. OYW
5592. OYY
5593. OYZ
5594. OZA
5595. OZB
5596. OZC
5597. OZD
5598. OZE
5599. OZF
5600. OZG
5601. OZH
5602. OZI
5603. OZJ
5604. OZK
5605. OZN
5606. OZO
5607. OZQ
5608. OZR
5609. OZT
5610. OZW
5611. OZX
5612. OZY
5613. OZZ
5614. PAA
5615. PAB
5616. PAD
5617. PAE
5618. PAF
5619. PAG
5620. PAH
5621. PAI
5622. PAJ
5623. PAL
5624. PAM
5625. PAN
5626. PAO
5627. PAP
5628. PAQ
5629. PAR
5630. PAS
5631. PAT
5632. PAV
5633. PAW
5634. PAX
5635. PAY
5636. PAZ
5637. PBA
5638. PBC
5639. PBD
5640. PBF
5641. PBH
5642. PBI
5643. PBJ
5644. PBL
5645. PBN
5646. PBP
Docket No. FDA-2017-N-6730
February 26, 2018
Page 46 of 50
5647. PBQ
5648. PBU
5649. PBX
5650. PBY
5651. PBZ
5652. PCA
5653. PCB
5654. PCC
5655. PCD
5656. PCE
5657. PCF
5658. PCG
5659. PCH
5660. PCI
5661. PCK
5662. PCL
5663. PCM
5664. PCN
5665. PCO
5666. PCQ
5667. PCS
5668. PCT
5669. PCU
5670. PCV
5671. PCW
5672. PCX
5673. PCY
5674. PCZ
5675. PDA
5676. PDB
5677. PDC
5678. PDD
5679. PDE
5680. PDF
5681. PDG
5682. PDH
5683. PDI
5684. PDJ
5685. PDK
5686. PDO
5687. PDQ
5688. PDR
5689. PDS
5690. PDT
5691. PDU
5692. PDW
5693. PDX
5694. PDY
5695. PDZ
5696. PEA
5697. PEB
5698. PEC
5699. PEF
5700. PEG
5701. PEH
5702. PEJ
5703. PEK
5704. PEM
5705. PEN
5706. PEO
5707. PEP
5708. PEQ
5709. PER
5710. PET
5711. PEU
5712. PEV
5713. PEW
5714. PEX
5715. PEZ
5716. PFA
5717. PFC
5718. PFE
5719. PFF
5720. PFG
5721. PFH
5722. PFJ
5723. PFK
5724. PFL
5725. PFM
5726. PFN
5727. PFP
5728. PFQ
5729. PFR
5730. PFS
5731. PFT
5732. PFU
5733. PFV
5734. PFW
5735. PFX
5736. PFY
5737. PFZ
5738. PGD
5739. PGE
5740. PGF
5741. PGG
5742. PGH
5743. PGI
5744. PGJ
5745. PGK
5746. PGM
5747. PGN
5748. PGO
5749. PGQ
5750. PGT
5751. PGU
5752. PGV
5753. PGW
5754. PGX
5755. PGY
5756. PGZ
5757. PHC
5758. PHF
5759. PHG
5760. PHJ
5761. PHK
5762. PHL
5763. PHM
5764. PHN
5765. PHO
5766. PHP
5767. PHQ
5768. PHR
5769. PHS
5770. PHT
5771. PHU
5772. PHV
5773. PHW
5774. PHX
5775. PHY
5776. PHZ
5777. PIA
5778. PIC
5779. PID
5780. PIE
5781. PIF
5782. PIG
5783. PIH
5784. PII
Docket No. FDA-2017-N-6730
February 26, 2018
Page 47 of 50
5785. PIJ
5786. PIK
5787. PIL
5788. PIM
5789. PIN
5790. PIO
5791. PIP
5792. PIQ
5793. PIR
5794. PIT
5795. PIV
5796. PIW
5797. PIX
5798. PIY
5799. PIZ
5800. PJA
5801. PJB
5802. PJC
5803. PJD
5804. PJE
5805. PJF
5806. PJG
5807. PJH
5808. PJI
5809. PJJ
5810. PJK
5811. PJM
5812. PJN
5813. PJO
5814. PJP
5815. PJQ
5816. PJS
5817. PJT
5818. PJY
5819. PJZ
5820. PKA
5821. PKB
5822. PKC
5823. PKD
5824. PKE
5825. PKF
5826. PKG
5827. PKI
5828. PKJ
5829. PKK
5830. PKL
5831. PKM
5832. PKN
5833. PKO
5834. PKP
5835. PKQ
5836. PKS
5837. PKT
5838. PKU
5839. PKW
5840. PKY
5841. PLA
5842. PLB
5843. PLC
5844. PLF
5845. PLH
5846. PLI
5847. PLK
5848. PLL
5849. PLO
5850. PLP
5851. PLQ
5852. PLR
5853. PLS
5854. PLV
5855. PLW
5856. PLY
5857. PMB
5858. PMC
5859. PME
5860. PMG
5861. PMH
5862. PMI
5863. PMJ
5864. PMK
5865. PML
5866. PMP
5867. PMQ
5868. PMS
5869. PMV
5870. PMX
5871. PMY
5872. PNC
5873. PND
5874. PNE
5875. PNG
5876. PNN
5877. PNO
5878. PNP
5879. PNR
5880. PNS
5881. PNV
5882. POA
5883. POC
5884. POE
5885. POG
5886. POI
5887. POJ
5888. PON
5889. POQ
5890. POR
5891. POT
5892. POV
5893. POW
5894. POX
5895. POY
5896. POZ
5897. PPA
5898. PPB
5899. PPC
5900. PPD
5901. PPE
5902. PPF
5903. PPG
5904. PPH
5905. PPI
5906. PPJ
5907. PPK
5908. PPL
5909. PPM
5910. PPN
5911. PPO
5912. PPP
5913. PPQ
5914. PPR
5915. PPS
5916. PPT
5917. PQC
5918. PQD
5919. PQE
5920. PQF
5921. PQH
5922. PQQ
Docket No. FDA-2017-N-6730
February 26, 2018
Page 48 of 50
5923. PQX
5924. PQY
5925. PQZ
5926. PRE
5927. PRF
5928. PRI
5929. PRJ
5930. PRK
5931. PRM
5932. PRN
5933. PRO
5934. PRP
5935. PRQ
5936. PRR
5937. PRS
5938. PRT
5939. PRU
5940. PRV
5941. PRW
5942. PRX
5943. PRY
5944. PRZ
5945. PSA
5946. PSB
5947. PSC
5948. PSD
5949. PSE
5950. PSF
5951. PSG
5952. PSH
5953. PSI
5954. PSJ
5955. PSK
5956. PSM
5957. PSN
5958. PSP
5959. PSQ
5960. PSS
5961. PST
5962. PSV
5963. PSW
5964. PSX
5965. PSZ
5966. PTB
5967. PTC
5968. PTD
5969. PTE
5970. PTF
5971. PTG
5972. PTH
5973. PTI
5974. PTJ
5975. PTK
5976. PTL
5977. PTM
5978. PTN
5979. PTO
5980. PTP
5981. PTQ
5982. PTR
5983. PTS
5984. PTT
5985. PTU
5986. PTV
5987. PTW
5988. PTX
5989. PTY
5990. PTZ
5991. PUA
5992. PUB
5993. PUC
5994. PUD
5995. PUE
5996. PUF
5997. PUG
5998. PUH
5999. PUI
6000. PUK
6001. PUL
6002. PUN
6003. PUP
6004. PUQ
6005. PUR
6006. PUW
6007. PUX
6008. PUY
6009. PUZ
6010. PVA
6011. PVB
6012. PVD
6013. PVE
6014. PVF
6015. PVG
6016. PVH
6017. PVI
6018. PVJ
6019. PVK
6020. PVL
6021. PVM
6022. PVN
6023. PVO
6024. PVP
6025. PVQ
6026. PVR
6027. PVS
6028. PVT
6029. PVU
6030. PVV
6031. PVW
6032. PVX
6033. PVY
6034. PVZ
6035. PWA
6036. PWC
6037. PWG
6038. PWH
6039. PWI
6040. PWJ
6041. PWK
6042. PWL
6043. PWM
6044. PWN
6045. PWO
6046. PWP
6047. PWQ
6048. PWR
6049. PWS
6050. PWT
6051. PWU
6052. PWV
6053. PWW
6054. PWX
6055. PWY
6056. PWZ
6057. PXA
6058. PXB
6059. PXC
6060. PXD
Docket No. FDA-2017-N-6730
February 26, 2018
Page 49 of 50
6061. PXE
6062. PXF
6063. PXG
6064. PXH
6065. PXI
6066. PXJ
6067. PXK
6068. PXL
6069. PXM
6070. PXN
6071. PXO
6072. PXP
6073. PXQ
6074. PXR
6075. PXS
6076. PXU
6077. PXV
6078. PXW
6079. PXX
6080. PXY
6081. PXZ
6082. PYA
6083. PYB
6084. PYC
6085. PYD
6086. PYE
6087. PYF
6088. PYG
6089. PYH
6090. PYI
6091. PYJ
6092. PYK
6093. PYL
6094. PYO
6095. PYP
6096. PYQ
6097. PYR
6098. PYS
6099. PYU
6100. PYV
6101. PYW
6102. PZC
6103. PZG
6104. PZH
6105. PZI
6106. PZN
6107. PZO
6108. PZS
6109. PZT
6110. PZU
6111. PZV
6112. PZX
6113. PZY
6114. PZZ
6115. QAB
6116. QAF
6117. QAG
6118. QAK
6119. RAA
6120. RAB
6121. RAC
6122. RAD
6123. RAE
6124. RAF
6125. RAG
6126. RAH
6127. RAI
6128. RAJ
6129. RAK
6130. RAL
6131. RAM
6132. RAN
6133. RAO
6134. RAP
6135. RAQ
6136. RAR
6137. RAS
6138. RAT
6139. RAU
6140. RAV
6141. RAW
6142. RAX
6143. RAY
6144. RAZ
6145. RBA
6146. RBB
6147. RBC
6148. RBD
6149. RBE
6150. RBF
6151. RBG
6152. RBH
6153. RBI
6154. RBJ
6155. RBK
6156. RBL
6157. RBM
6158. RBN
6159. RBO
6160. RBP
6161. RBQ
6162. RBR
6163. RBS
6164. RBT
6165. RBU
6166. RBV
6167. RBW
6168. RBX
6169. RBY
6170. RBZ
6171. RCA
6172. RCB
6173. RCC
6174. RCD
6175. RCE
6176. RCF
6177. RCG
6178. RCH
6179. RCI
6180. RCJ
6181. RCK
6182. RCL
6183. RCM
6184. RCN
6185. RCO
6186. RCP
6187. RCQ
6188. RCR
6189. RCS
6190. RCT
6191. RCU
6192. RCV
6193. RCW
6194. RCX
6195. RCY
6196. RCZ
6197. RDA
6198. RDB
Docket No. FDA-2017-N-6730
February 26, 2018
Page 50 of 50
6199. RDC
6200. RDD
6201. RDE
6202. RDF
6203. RDG
6204. RDH
6205. RDI
6206. RDJ
6207. RDK
6208. RDL
6209. RDM
6210. RDN
6211. RDO
6212. RDP
6213. RDQ
6214. RDS
6215. RDT
6216. RDU
6217. RDV
6218. RDW
6219. RDX
6220. RDY
6221. RDZ
6222. REA
6223. REB
6224. REC
6225. RED
6226. REE
6227. REF
6228. REG
6229. REH
6230. REI
6231. REJ
6232. REK
6233. REL
6234. REM
6235. REN
6236. REO
6237. REP
6238. REQ
6239. RER
6240. RES
6241. RET
6242. REU
6243. REV
6244. REW
6245. REX
6246. REY
6247. REZ
6248. RFA
6249. RFB
6250. RFC
6251. RFD
6252. RFE
6253. RFF
6254. RFG
6255. RFI
6256. RFJ
6257. RFK
6258. RFL
6259. RFM
6260. RFN
6261. RFO
6262. RFP
6263. RFQ
6264. RFR
6265. RFS
6266. RFT
6267. RFU
6268. RFV
6269. RFW
6270. RFX
6271. RFY
6272. RFZ
6273. RGA
6274. RGB
6275. RGC
6276. RGD
6277. RGE
6278. RGF
6279. RGG
6280. RGH
6281. RGI
6282. RGJ
6283. RGK
6284. RGM
6285. RGN
6286. RGO
6287. RGP
6288. RGQ
6289. RGS
6290. RGT
6291. RGU
6292. RGV
6293. RGW
6294. RGX
6295. RGY
6296. RGZ
6297. RHA
6298. RHB
6299. RHC
6300. RHD
6301. RHF
6302. RHG
6303. RHH
6304. RHI
6305. RHJ
6306. RHK
6307. RHL
6308. RHM
6309. RHN
6310. RHO
6311. RHP
6312. RHQ
6313. RHR
6314. RHS
6315. RHT
6316. RHU
6317. RHV
6318. RHW
6319. RHX
6320. RHY
6321. RHZ
6322. RIA
6323. RIB
6324. RIC
6325. RID
6326. RIE
6327. RIF
6328. RIG
6329. RIH
6330. RII
6331. RIJ
6332. RIK
AdvaMed Comment Form
Voluntary Malfunction Summary Reporting Program for Manufacturers, Notice and Request for Comments (Docket No. FDA-2017-N-6730)
# Page/Section Comment/Proposed Change Rationale
General Comments FDA should explain how this program replaces and/or works in conjunction
with other alternative summary reporting situations, particularly if a
manufacturer has an alternative system in place. In addition, FDA should
describe whether and how summary malfunction reporting information will
be shared with the global network of national competent authorities through
NCAR.
This information will clarify how this program interacts
with existing ones.
60924, Section III. We believe this program should be available to device importers, as well as
domestic manufacturers.
The same rationales FDA cites for the program benefits
would apply to importers as well. The Notice does not
explain why the program should not be available to
device importers.
60925, first
paragraph
We recommend that FDA clarify that a firm does not need to apply or
otherwise obtain permission to take advantage of this program.
We believe a firm should be eligible to take advantage of
the summary reporting program so long as the conditions
identified in the Notice are met.
60925, Section
III.A.1 (second
paragraph)
FDA should define the term “substantially similar.” Additional clarity would aid the reader’s understanding
of this section.
60925, Section
III.A.2
We disagree with the inclusion of the following criteria: When “a device is
the subject of a recall involving the correction or removal of a marketed
product to address a malfunction, all reportable malfunction events of the
same nature that involve the same device or similar device . . . must be
submitted as individual MDRs.”
This provision should be removed for several reasons. First, it will be very
difficult for manufacturers to manage this requirement because new event
details may be uncovered during a product investigation leading to
confusion and multiple reports for the incident. Second, nowhere in the
MDUFA IV Commitment Letter is this concept mentioned. And third,
during a recall FDA would receive all relevant information, making this
requirement duplicative.
Manufacturers routinely elect to perform voluntary
recalls based on internal risk processes and their
acceptability of residual risk. The statement, should it
apply to voluntary recalls, could discourage manufactures
from performing such field actions.
Recall classifications are determined by the Agency after
a manufacturer reports a field correction. This process
and time for recall classification decisions may lead to
confusion as to whether an event can follow the proposed
summary reporting mechanism or necessitates an
individual MDR submission.
AdvaMed Comments
Voluntary Malfunction Summary Reporting Program for Manufacturers, Notice and request for comments (Docket No. FDA-2017-N-6730)
2
# Page/Section Comment/Proposed Change Rationale
FDA must justify this provision should it remain part of the program. There
is no current justification provided, and as we state above, there are
numerous reasons why it should be removed.
If this provision is maintained, which we do not believe is appropriate, it
should apply only to class I recalls as classified by FDA.
Furthermore, we suggest FDA clarify that “malfunction events of the same
nature” apply only to the same device malfunction in the same way as
described in the device recall.
Class II and III recalls do not present the same level of
risk as class I recalls.
This statement would further clarify the Notice.
60925, Section
III.A.3
We recommend including information on the timing for when FDA would
provide a firm with written notice that they may resume participation in the
program, or in the alternative, to explain when a manufacturer can request to
resume participation in the program.
The addition of timing allows industry to know that it is
still under consideration or to allow industry the
opportunity to ensure that the potential for resuming
participation is not lost.
60925, Section
III.A.5
It is not clear whether subsequent malfunctions of that type (which are
therefore no longer “a new type of malfunction”) can be submitted through
the Malfunction Reporting Summary Format, but this would be a logical
outcome. We recommend FDA provide clarity on follow-up submissions in
the event that new information regarding an event would necessitate an
update.
This addition will provide clarification to readers.
We recommend clarifying the statement, “the reportable malfunction is a
new type of malfunction that the manufacturer has not previously reported to
FDA for that device.”
It is unclear whether a “new type of malfunction” refers
to unanticipated events not described in risk
documentation or any type of new, unreported events. It
is also unclear whether “that device” means an individual
catalog number, or if it refers to similar devices in a
product code.
In the case of a new type of device malfunction, FDA should provide
additional information concerning when the manufacturer can resume
participation in this summary reporting program. We believe a 90-day
window for individual MDR reports would be appropriate, after which time
the manufacturer can resume participation in this summary reporting
program.
We believe 90 days provides sufficient time for the
manufacturer to collect information and investigate the
new malfunction.
AdvaMed Comments
Voluntary Malfunction Summary Reporting Program for Manufacturers, Notice and request for comments (Docket No. FDA-2017-N-6730)
3
# Page/Section Comment/Proposed Change Rationale
60925, Section
III.B.1
We recommend FDA provide further information concerning how a
manufacturer is to provide supplemental information, including whether
FDA expects such information to be shared with the Agency. If
supplemental information is expected, details including the process to do so
should be included.
This clarification will assist readers’ understanding of the
program.
60925, Section
III.B.1 (example)
The example provided in the document is confusing. We recommend FDA
better clarify the reporting mechanisms for the various device issues.
This clarification will assist readers’ understanding of the
program.
60925, Section
III.B.1
This summary report requires an individual to process the complaints twice:
Once to determine reporting assessment and then, quarterly, a review of all
complaints to determine how they are reported in the summary report.
Consider amending the requirement. This does not seem
to be in the interest of or “in consideration of least
burdensome means of reporting.”
60925, Section
III.B.1
We recommend FDA provide additional information concerning how a
previously submitted summary malfunction report should be updated with
new information (e.g., a fluid loss complaint can be updated with infection
event information).
This information will clarify the requirements of the
program.
We recommend FDA provide more detail concerning its use of the phrase
“similar device” and “similar complaint” in light of FDA’s statement that
summary reporting should not be duplicative.
Additional clarity would be helpful in understanding
FDA’s intent with these phrases.
60926, first full
paragraph
FDA should allow Excel spreadsheets to be uploaded to the MAUDE
database. If Excel is not an option, FDA should permit one report per device
product to be submitted with a narrative breakout within that single report to
identify the various groupings (rather than separate reports for each
grouping)
• The current program design would be more time
consuming than providing data in an Excel output.
• Excel format would allow end users to filter and
extract the data they need, including lot number and
associated malfunction with associated reported
events.
• If all information is contained in a single report, it is
less likely to duplicate content since all information
for a given device is contained in the same report.
• Submission tracking of a single periodic report to
multiple devices and cases would be time consuming
and prone to human error.
• In the proposed format, a person would have to read
each narrative to gather the information needed to
analyze the data.
AdvaMed Comments
Voluntary Malfunction Summary Reporting Program for Manufacturers, Notice and request for comments (Docket No. FDA-2017-N-6730)
4
# Page/Section Comment/Proposed Change Rationale
• It takes more time to package larger submissions.
60926, Section
III.B.2
With respect to the statement: “Separate summary malfunction reports
would be submitted for each unique combination of device model and
problem code(s),” we recommend FDA permit individual MDRs for each
reportable event while using the summary format proposed in Section
III.B.2.
The alternative methodology would allow the flexibility
to accommodate differences in existing processes at
various manufactures. For example, manufacturers might
have several cases where the model and problem codes
are the same. In each case, for example, a valve may have
failed, but it might be a different valve controlling a
different function. By allowing individual MDRs in the
summary format, manufacturers of large clinical IVDs
can save significant time without sacrificing relevant
information.
60926, Section
III.B.2 (Section B.5
of Form FDA 3500A)
We believe the Section B.5 information should be entered in a summary,
high-level form, rather than a “detailed” description.
Requiring such detailed information to be entered in
Section B.5 minimizes the utility of this program.
FDA should require that information submitted in Section B.5 describe the
malfunction that occurred and the most common circumstances that the
malfunction occurred in. Additionally, if the summary report is populated
with level 1 coding from FDA’s new format based on the IMDRF code
restructure, then Section B.5 can list the level 2 and level 3 codes applied in
this subset.
We recommend FDA provide clarity regarding the most “up to date”
information that is expected to be received in the report. Moreover, FDA
should expect that the submitted data be accurate as of the time period for
which it’s pulled by the manufacturer for the report.
The extensive request of this section may limit any value
potentially realized from summary reporting, thus making
it prohibitive. Instead, industry should provide a
summary of the malfunction at an overall level as well as
the most common context to assist FDA in understanding
the malfunction that shows the failure mode in a more
understandable format. Should FDA need/want to see the
individual event details, they would be available during
an inspection.
We believe that patient characteristics such as a range of patient age and
weight, and a breakdown of gender, race and ethnicity, is inappropriate for
summary reporting.
Because there is no injury, the patient characteristics are
not relevant to the malfunction that occurred and do not
provide relevant device information.
60926, Section
III.B.2 (Section D.1
of Form FDA 3500A)
We recommend FDA clarify that only one brand name per product code
should be entered in this field, with additional brand names being provided
in an attachment. Entering all possible brand names could result in many
reports.
Requiring such detailed information to be entered in
Section D.1 minimizes the utility of this program and
does not align with the Agency’s least burdensome
principles.
AdvaMed Comments
Voluntary Malfunction Summary Reporting Program for Manufacturers, Notice and request for comments (Docket No. FDA-2017-N-6730)
5
# Page/Section Comment/Proposed Change Rationale
60926, Section
III.B.2 (Section D.4
of Form FDA 3500A)
We recommend revising the text as follows: “Enter the model and/or catalog
number and lot number(s) or serial number(s) for the devices that are the
subject of the MDR.”
The option to use serial numbers rather than lot numbers
is needed since many devices use serial numbers.
FDA should modify Form 3500A, or provide an alternative methodology, to
allow entry of multiple lot, catalog and serial numbers that are the subject of
the MDR.
Currently, this section only accepts a single lot number,
and the case examples do not address this situation.
In the case where a single summary report includes more than one device
problem, FDA should clarify how a manufacturer should link a device
problem code with a method code, result code, and evaluation conclusion
code (if different) in the summary format.
This information will provide further clarity.
FDA should further clarify the products that can be bundled together for
summary reporting (e.g., by product code, product family, product base list
number). Similarly, FDA should allow for the option to accept multiple
summary reports per product model/device problem codes.
We believe summary reporting by “like” products would
be accomplished by using product families as a
demarcation. Device problem codes are generic and
therefore may include too many different malfunctions,
which would make the narrative (B5) and investigation
sections (H10) very complicated and difficult to
understand.
60926, Section
III.B.2 (Section G.1
of Form FDA 3500A)
We recommend FDA clarify that summary reports for the same device and
problem can be submitted if the device is manufactured at multiple sites.
As written, it appears only devices manufactured at the
same site would be able to take advantage of the
summary reporting program. “Like products” can be
made by multiple manufacturing sites.
60926, Section
III.B.2 (Section H.6
of Form FDA 3500A)
We recommend FDA permit the use of Level 1 and 2 IMDRF codes to
bundle like cases for summary reporting.
Newly developed IMDRF codes are very specific, such
that the unique combinations of codes that apply to a
population of cases is likely to be highly variable. The
suggestion that the cases should be bundled into unique
populations of similar code combinations will result in
very few cases being bundled into a single summary
report. Therefore, the actual reduced burden of summary
reporting could be significantly less than estimated.
AdvaMed Comments
Voluntary Malfunction Summary Reporting Program for Manufacturers, Notice and request for comments (Docket No. FDA-2017-N-6730)
6
# Page/Section Comment/Proposed Change Rationale
60926, Section
III.B.2 (Section H.10
of Form FDA 3500A)
FDA should request summaries/explanations of the general investigation and
resulting findings/conclusions/confirmations that there are no new root
causes (or if there are new root causes, what they are and what the
manufacturer did), rather than requiring the manufacturer to itemize the
findings of the collective investigations.
The extensive request of this section may limit any value
potentially realized from summary reporting. Instead,
industry should be expected to provide a summary of the
investigation at an overall level as well as relevant
context to assist FDA in understanding the malfunction
and actions taken. This would not alter the
manufacturer’s obligation to conduct individual
investigations for each event, only the reporting of them.
Should FDA request to view the individual
investigations, they would be available.
60926, Section
III.B.3
Where there is no death or injury to the patient, summary reporting should
apply to combination products and be included with the malfunction
summary report as a single report to satisfy both reporting requirements.
The need to report combination products individually
reduces the benefit for summary reporting. Instead of
summary reporting, the manufacturer will likely file
individual reports to include both combination product
requirements and Part 803 malfunction requirements
rather than an individual report for combination product
reporting and a summary report for the Part 803 report.
60926, Section III.C After the first sentence, “Under the proposed program, manufacturers
submitting summary malfunction reports would be required to use electronic
reporting (Ref. 6) to submit those reports on a quarterly basis according to
the schedule in table 1,” we recommend adding: “Alternatively,
manufacturers choosing to submit individual event reports using the
summary format would have 90 calendar days from the date they become
aware in which to file the MDR.”
Having 90 days to submit individual reports in summary
format would significantly reduce the number of follow-
up reports required. This is a time and cost saving for
both the manufacturer and FDA.
60927, Table 1 We recommend FDA provide an additional 30 days for the submission of
reports.
While the program will likely lead to a lower number of
reports being submitted to the Agency, summary
reporting still requires significant efforts by the
manufacturer (e.g., identification, evaluation, grouping,
writing, submitting, tracking), and reportability of new
events will continue to be determined during the 30-day
period following the last awareness date in each quarter.
Depending upon the volume of reports that need to be
aggregated, the manufacturer (whether a medical device
AdvaMed Comments
Voluntary Malfunction Summary Reporting Program for Manufacturers, Notice and request for comments (Docket No. FDA-2017-N-6730)
7
# Page/Section Comment/Proposed Change Rationale
or combination product) may need more than one month
between the end of the reporting period and due date. As
a result, the proposed timelines do not allow enough time
to compile the summary reports.
The table and accompanying information fails to provide information
explaining what the manufacturer should do if an investigation is not
complete within the reporting timeframe. We recommend the Agency adopt
the Alternative Summary Reporting rule’s policy that any unfinished
investigations be reported during the following quarter.
Investigations, at times, require collaboration with
suppliers and/or waiting on a device to be returned from a
customer, which pushes timelines past the quarterly
reporting deadline. While investigations remain open,
more clarification regarding in which quarter to report the
malfunction would be helpful.
60927, first
paragraph
We recommend using a more generic reporting number format or a
completely different reporting number format for the Voluntary Malfunction
Summary Reporting.
If the manufacturer’s database automatically generates
the MDR number for the expedited device reporting
forms and the voluntary summary malfunction reporting
is not conducted within the manufacturer’s database but
is still submitted via the low volume submitter, it would
be difficult to assign an appropriate MDR number.
The summary reporting mechanism should permit reports to be submitted
based on a product’s procode regardless of the manufacturing registration
number. We are concerned that, as currently proposed, malfunctions for a
specific procode will only be able to be grouped by manufacturing
registration number.
The program should tie summary reports to
manufacturing.
60927 We are unable to provide feedback on this process from a combination
product perspective at this time, as guidance on the Final Rule for Post-
Market Safety Reporting for Combination Products for provision of
additional information via the expedited route has not yet been released.
N/A
60927; Section III.E. FDA should more clearly explain how industry should make a request under
803.19(b), including the type of information FDA would expect to receive.
Moreover, while industry agrees that, in general, product codes in existence
for less than two years should be ineligible for inclusion this program, FDA
should provide a mechanism for industry to request an exemption, when
appropriate, for product codes that may be newly assigned within a given
two-year window.
Additional clarity is needed with respect to making such
requests.
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