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5 revised 4 withdrawn 15 new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