Office of In Vitro Diagnostic Device Evaluation and Safety

1. Office of In Vitro Diagnostic Device Evaluation and Safety Donald St.Pierre Deputy Director for New Device Evaluation AdvaMed’s 13th Annual Device Submissions Workshop

2. The Story Line • Organization & Resources • Workload • Review Statistics • MDUFMA

3. ORGANIZATION &RESOURCES

4. Structure - OIVD • Single Organizational Unit • Premarket • Compliance • Post-market • One Stop Shopping • Delayered – no more branches • Streamlined – minimal administrative support

5. OIVD (con’t) • Goals • Increased Transparency • Uniform Least Burdensome Approach • Expedited Technology Transfer • Improve Connectivity and Quality of Work • Objective - TPLC • Common Technical Base • Faster Response Time

6. SEE ORGANIZATIONAL CHART

7. Thanks to MDUFMA • Approaching FY01 Staffing Level • 11th Annual Workshop – 66 • 12th Annual Workshop – 54 • 13th 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

8. Parallel to other offices • ODE • Same commitments, responsibilities • Adopt spirit of LB, summaries/balance • OC • Same commitments, responsibilities • Still learning, moving 510(k)s this direction, 30-day notice changes, tracking, MOU • OSB • Eggs in MedSun basket • Move from MDRs to active surveillance

9. Other Offices - Projects • OST • Software support • Guidance collaboration • OHIP • Still some pt labeling/human factors • OIVD website • OSM • Collaborative software, databases, tracking, eReview

10. External Outreach • IVD Roundtable • Professional IVD Roundtable • Pharmacogenomic Roundtable • Therapeutic Drug Management RT • Internal Staff College • NIH/NCI • CDC/CMS • SAMHSA

11. II. WORKLOAD

12. PMA Receipts (½ FY03)

13. 510(k) Receipts (½ FY03)

14. Other OIVD Documents

15. Other Receipts (½ FY03)

16. Standards Activities • 5 revised • 4 withdrawn • 15 new (See 4/28/03 FR notice)

17. 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 products Current IVD harmonization projects: • classification • labeling • IVD premarket conformity with principles for safety and performance • STED (?)

18. 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

19. Guidances In-the-Works • Coagulation • NIOX and 1 other Denovo • Replacement Reagent • Glucose • IVD Device Studies (BiMo)

20. 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

21. Other Resource Issues • Classifications – Herpes, B. Anthracis, Yersinia Pestis • Scorecards • CBER/CDRH interactions • CPI • TPLC/Patient Safety • SARS/WNV • ASRs/Genetics • CLIA/OC

22. 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

23. 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

24. Ongoing Activities • Performance Scorecards • Looking for measurable outcomes (e.g.,) • Decrease enforcement actions • Decrease recalls • Decrease MDRs • Decrease review times • Increase decision quality • Improve BiMo audit results • Measure feedback

25. 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

26. 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

27. Review Statistics

28. Original PMA Approvals

29. PMA Supplement Approvals

30. ½ FY03 510(k) Review Stats

31. 510(k) Review Stats

32. CLIA Workload

33. IV. MDUFMA Participating on implementation teams Providing input on Guidances Clarifying terminology Bundling

34. 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

35. 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