Office of In Vitro Diagnostic Device Evaluation and Safety
Donald St.PierreDeputy Director for New Device Evaluation
AdvaMed’s 13th Annual Device Submissions Workshop
The Story Line
Organization & Resources Workload Review Statistics MDUFMA
I. ORGANIZATION &RESOURCES
Structure - OIVD
Single Organizational Unit Premarket Compliance Post-market One Stop Shopping Delayered – no more branches Streamlined – minimal administrative support
OIVD (con’t)
Goals Increased TransparencyUniform Least Burdensome ApproachExpedited Technology Transfer Improve Connectivity and Quality of Work
Objective - TPLC Common Technical Base Faster Response Time
SEE ORGANIZATIONAL CHART
Thanks to MDUFMA Approaching FY01 Staffing Level
11th Annual Workshop – 6612th Annual Workshop – 5413th Annual Workshop – 63
Doug Wood (DCTD - 5/18) Cecily Jones (DIHD – 6/1) Marieanne Brill (DMD – 6/1) 3 more are in-process Total Projected --70-75 by EOY
Parallel to other offices ODE
Same commitments, responsibilitiesAdopt spirit of LB, summaries/balance
OCSame commitments, responsibilitiesStill learning, moving 510(k)s this direction, 30-
day notice changes, tracking, MOU OSB
Eggs in MedSun basketMove from MDRs to active surveillance
Other Offices - Projects
OSTSoftware supportGuidance collaboration
OHIPStill some pt labeling/human factorsOIVD website
OSMCollaborative software, databases,
tracking, eReview
External Outreach IVD Roundtable Professional IVD Roundtable Pharmacogenomic Roundtable Therapeutic Drug Management RT Internal Staff College NIH/NCI CDC/CMS SAMHSA
II. WORKLOAD
PMA Receipts (½ FY03)
Original PMAs 2
Normal PMA/S 8
Panel-Track PMA/S 1
Real-Time PMA/S 12
30-day notice 15
Special PMA/S 9
PMA Modules 8
510(k) Receipts (½ FY03)
All 510(k)s 361
Traditional 315
Abbreviated 14
Special 32
Other OIVD Documents
Pre-IDE Pre-IDE
Supple.
IDE IDE Supple.
FY99 55 10 1 11
FY00 64 11 3 8
FY01 85 16 1 10
FY02 96 33 4 9
½ FY03 39 15 1 0
Other Receipts (½ FY03)
HDE 0
PDP 0
513(g) 9
Standards Activities
5 revised 4 withdrawn 15 new
(See 4/28/03 FR notice)
GHTF CDRH active in all Study Groups (SG); OIVD
active in SG 1 (POC - Ginette Michaud) SG1: operational aspects of medical device
regulation including IVD productsCurrent IVD harmonization projects: classification labeling IVD premarket conformity with principles
for safety and performance STED (?)
FY03 Guidance Documents
Multiplex Tests for Heritable DNA Markers, Mutations and Expression Patterns
Antimicrobial Susceptibility Test (AST) Systems
Analyte Specific Reagents; Small Entity Compliance Guidance
Guidances In-the-Works
Coagulation NIOX and 1 other Denovo Replacement Reagent Glucose IVD Device Studies (BiMo)
OIVD Counter Terrorism Activities
Established emergency response plans, in conjunction with HHS and FDA, to monitor and respond to a terrorist event
Expediting the review of device submissions related to counter terrorism and military need
Evaluating the safety and effectiveness of diagnostic test kits that detect biothreat agents
Participated in TOPOFF Exercise
Other Resource Issues
Classifications – Herpes, B. Anthracis, Yersinia Pestis
Scorecards CBER/CDRH interactions CPI TPLC/Patient Safety SARS/WNV ASRs/Genetics CLIA/OC
On the Web FY03
510(k) - IDI Strep B for Preg. Women 510(k) - pro-BNP for CHF 510(k) - Home Glycated Hemoglobin for
Diabetics 510(k) - Cobalt Albumin to rule out Heart
Attack 510(k) - Breath test for Asthma 510(k) - Aspergillus
On the Web FY03
Lab Safety Tips Accu Chek class II Recall SSED - P020027 (FPSA) SSED - P020011 (HCV) IVD 510(k) Workshop Expanded use for HPV Consumer Information
Ongoing Activities
Performance ScorecardsLooking for measurable outcomes (e.g.,)
Decrease enforcement actions Decrease recalls Decrease MDRs Decrease review times Increase decision quality Improve BiMo audit results Measure feedback
Ongoing Activities
New IVD Webpage (good first effort)www.fda.gov/cdrh/oivd
Standardizing review format Learning about compliance Learning about post-market MedSun to LabSun Post-market safety team
Post-Market Safety Team - Themes
Consumer education/outreach Internal training (522 authority, STAMP,
safety alerts, public health advisories/notifications, MDRs, MedWatch, MedSun)
Tap Epi group – databases/literature Pick a disease and focus Active Surveillance ideas
III. Review Statistics
Original PMA Approvals
# of Decisions
Ave
FDA
Time
Ave
MFG
Time
Ave
Total
Time
FY02 OIVD
ODE
7
41
221
259
45
105
266
364
½ FY03 OIVD
ODE
3
14
216
261
24
143
240
404
PMA Supplement Approvals
# of Decisions
Ave
FDA
Time
Ave
MFG
Time
Ave
Total
Time
FY02 OIVD
ODE
54
532
145
96
19
28
164
124
½ FY03 OIVD
ODE
30
270
81
83
13
31
94
114
½ FY03 510(k) Review Stats n FDA
time
MFG time
Total
time
All 510(k)s OIVD
ODE
354
2164
56
75
13
28
69
103
Trad. OIVD
ODE
312
1643
59
86
14
33
73
119
Abbrev. OIVD
ODE
10
109
48
75
11
20
59
95
Special OIVD
ODE
32
412
26
28
4
8
30
36
510(k) Review Stats
FY02 ½ FY03
Ave # of cycles OIVD
ODE
1.43
1.40
1.31
1.40
Ave # FDA days/cycle OIVD
ODE
45
55
43
53
Ave # MFG days/cycle OIVD
ODE
43
64
40
60
CLIA Workload
0
200400
600800
10001200
14001600
18002000
FY99 FY00 FY01 FY02 FY03
WaivedModerateHigh
IV. MDUFMA
Participating on implementation teams
Providing input on Guidances
Clarifying terminology
Bundling
Bundling Principles
Historically Done – continue Not Historically Done – don’t, unless it
makes sense & can be reviewed efficiently Second thoughts on our part (e.g., HBV) Guidance Coming No fee for Replacement Reagents
Challenges for the New Millennium
CLIA waiver Genetic Diseases/ASRs Microarrays/High throughput assays Turbo 510(k) TPLC Integrating all the work of the Center
into OIVD