1. OIVD - 11/17/02 Organization in place Educational programs in place Transfer of compliance Transfer of surveillance Learning by experience Charrette to ensure focus

2. Office Management Steve Gutman, M.D, Director Don St. Pierre, Deputy Director James Woods, Deputy Director Joseph Hackett, Ph.D., Associate Director Sousan Altaie, Ph.D., Scientific Policy Advisor

3. Chemistry Devices Jean Cooper, DVM, Director Carol Benson, Team Leader, Chemistry Alberto Gutierrez, Ph.D., Team Leader, Toxicology

4. Hematology/Immunology Tim O’Leary, Ph.D., M.D., Director Josie Bautista, Team Leader, Hematology Maria Chan, Ph.D., Team Leader, Immunology

5. Microbiology Sally Hojvat, Ph.D., Director Freddie Poole, Deputy Director

6. SACGT Recommendations Challenging Broad menu for HHS with suggestions for enhancements in oversight by CMS, FDA, and CDC FDA charged with regulating new genetic tests

7. SACGT Recommendations Risk based Non-chilling Informed by professional societies

8. FDA Planning Unresolved issues Legal authorities

9. FDA Work Plan FDA has asserted authority over ASRs FDA is considering possibility of incremental changes

10. FDA Plan Internal documents developed Ongoing discussion Very complicated issues

11. FDA Plan Central issue is risk assessment Challenging issue for SACGT Challenging issue for FDA Input expected from outside groups Input welcome

12. Microarray/Other Technology Under statute by default new device is class III ASR is one type of new device Microarray may not be class I exempt if it falls outside description of class I

13. Statutory/Regulatory Limitations All devices have limitations to exemption Even microarrays that might satisfy description of ASR classifications may trip limitations

14. Extensive Discussion Nuanced issues Complex issues FDA commitment to clarify

15. If Premarket Notification Submission Is Required If a given microarray cannot be found SE to a legally marketed predicate ASR, it becomes class III Devices remain class III unless given a new classification by formal classification or new statutory option of de novo classification

16. De Novo 510(k)s Flexible option when appropriate Fast option when needed Broad option -- TDM Round Table

17. FDA Revisit of ASRs Not focused on genetic testing alone Part of overall risk management initiatives without genetic exceptionalism Likely to take time

18. FDA Revisit of ASRs Likely to be collaborative with other parts of HHS Likely to emphasize Commissioner’s goals of risk based and economic regulation Likely to emphasize Commissioner’s goal of consumerism

19. Alternative Review Models IVAT TPLC model

20. Alternative Review Models IVAT – dockets open TPLC model – internal to Round Table Public Discussion -- minutes

21. Alternative Review Models Common core issues Comport to public health mission Comport to law

22. IVAT Model Well established, classified analytes is the norm Clear intention is for more novel subsets

23. IVAT Model How to delineate between investigational and clinical phase of use? How to classify without specific indications for use? How to address clinical validation?

24. TPLC Model Lack of understanding of how model relates to FDA determination that new device is as safe and effective as predicate – threshold addressed Concerns over certification process for quality systems Link between hazard analysis and SE not clear

25. TPLC Model Challenge to refine and illuminate by example

26. Change in Review Practice More incremental Based on current tools Not challenge regulations or statutes

27. Template Based Review Posting review memos Home made template Work backwards Create turbo 510(k)

28. Template Based Review Electronic format Paper format Review is 1040 and supporting information in schedule A, B, C etc. Submit turbo 510(k) Review fast

29. Template Based Review Objectives similar although quantitatively different -- focused and fast reviews Allow for TPLC approach in or around model

30. Inherent Value of IVAT Model for establishing analytical performance Question at SACGHS

31. Value of TPLC model Need to refine regulation in the context of a bigger picture than premarket review Need to consider risk management in a more concrete manner Need to consider conformance between QSRs and ISO approaches

32. SARS CDC IDE De novo West Nile SARS workshop SARS guidance on hold – sort through complex issues Working with companies individually -- build experience needed

33. Informed Consent No OIVD level activity in this area Does industry plan to weigh in Changing environment Current recommendations -- talk to your IRB

34. Compliance Learning phase First choice to work with companies informally to identify and correct problems Second choice is to use regulatory tools Some cases second choice comes first by requirement or default

35. Issue of Patient Safety Profound cultural change Commissioner initiatives for risk management, economic regulation, and consumerism CDC and quality institute Seeking innovative programming May be gold in these hills

36. General Compliance Themes Coordinated work groups Use of OIVD web page to communicate issues Better use of existing signals Collaborating with industry to heighten safe use of laboratory devices

37. OIVD Objectives Not unique Use Fee Goals TPLC Contribute to Commissioner’s Strategic Plan

38. OIVD -- 11/17/03 Organization in transition Moving toward different regulatory model Not always smooth Not always fast and direct Challenging, dynamic, and entrepreneurial industry that always makes this work important and fun!