Medical Device Provisions of the FDA Amendments Act of 2007

1. Medical Device Provisions of the FDA Amendments Act of 2007

2. Presentation Outline • Title II Medical Device User Fee Amendments • MDUFMA II Performance Goals • Title III Pediatric Medical Device Safety and Improvement Act • Title VIII Clinical Trial Databases • Title VI Reagan-Udall Foundation • Title VII Conflicts of Interest • Title XI Other Provisions

3. Title II MDUFMA II New Definitions • 30-Day Notice • 513(g) Requests • Annual Periodic Reports • Establishment Subject to Annual Registration Fees

4. Authority To Assess and Use Device Fees

5. Authority To Assess and Use Device Fees • Payment • Refunds for modular PMAs • Annual establishment registration fee

6. Annual Fee Setting Small Businesses Fee Reductions • Foreign Small Business qualification • Reduced fees for Small Businesses Conditions of Trigger • Maintains same trigger from MDUFMA I • Device appropriations adjusted for inflation

7. Annual Fee Setting Crediting and Availability of Fees • $48 Million for FY 2008 • $52 Million for FY 2009 • $57 Million for FY 2010 • $61 Million for FY 2011 • $67 Million for FY 2012 • Offset Delayed Until FY 2012 fees

8. Annual Fee Setting Annual Reports • Performance Report • Financial Report Reauthorization Procedures • Public input prior to negotiations • Monthly updates to patient and consumer groups • Public review of final recommendations • Minutes of negotiation meetings on FDA Website

9. Annual Fee Setting Additional Authorization for Postmarket Safety • $7.1 Million in FY2008 • Adjusted each FY by 5% Effective Date • October 1, 2007 Sunset Clause • October 1, 2012

10. Extension of Third Party Review Program • Sunsets October 1, 2012

11. Registration • Changes registration to the first quarter of Fiscal Year (Oct. 1 to Dec.31) • Requires foreign establishments to register

12. Filing of List of Devices • Requires Listing of devices in the first quarter of Fiscal Year

13. Electronic Registration and Listing • Requires Registration and Listing to be done electronically

14. GAO Report on 510(k) Process • Study on appropriate use of 510(k) process • “Safe and effective as a classified device” • Evaluation of intended uses and technologies • Report due October 1, 2008

15. Unique Device Identification System • Regulations requiring label of device to bear a Unique Identifier • Alternative placement or exemption allowed • May include information on lot or serial number • Identify device through distribution and use

16. Frequency of MDR Reporting for Certain Devices • Permits quarterly summary reporting of malfunction MDRs • Devices designated by the Secretary • Cannot be Class III or implantable, life sustaining, life supporting Class II

17. Third Party Inspection Program • Reduces some procedural barriers • Only facilities with recent NAI inspections eligible • Allows submission of ISO 13485 reports for FDA’s inspectional priorities

18. GAO Study of Nosocomial Infections Number due to new and reused Devices Causes Including: • Reprocessing of Single Use Devices • Handling of sterilized devices • Hospital infection control practices • Health care professionals’ practices

19. FDA Report on Labeling of Tanning Devices • Labeling requirements adequate • Consumer understanding of label warnings • FDA report due October 1, 2008

20. MDUFMA II Performance Goals Quantitative Goals • Goals measured in FDA days • Decision goals-no cycle goals • Goals apply to FY2008 to 2012 Original PMAs, Panel-track PMA Supplements and Premarket Reports • 60% in 180 days • 90% in 295 days

21. MDUFMA II Performance Goals Expedited PMAs, Panel-track PMA Supplementsand Premarket Reports • 50% in 180 days • 90% in 280 days PMA Modules • 75% in 90 days • 90% in 120 days

22. MDUFMA II Performance Goals 180-day PMA Supplements • 85% in 180 days • 95% in 210 days Real-time Supplements • 80% in 60 days • 90% in 90 days

23. MDUFMA II Performance Goals 510(k) Submissions • 90% in 90 days • 98% in 150 days

24. Qualitative Goals Interactive Review • FDA will issue guidance 3 months post enactment • Promote informal communications between FDA and sponsor • FDA will use all forms of communication • Sponsor is expected to respond to requests in agreed upon time • If requested information is not received, FDA will stop the review clock

25. Qualitative Goals Meetings • FDA will scheduled informal and formal meetings in timely manner

26. Qualitative Goals Quarterly Performance Reports • FDA will provide performance updates to industry • FDA will also track total time from receipt to final decision • De-identified review branch performance annually

27. Qualitative Goals Reviewer Training • Summary information on types of training provided annually

28. Qualitative Goals Guidance Document Development • FDA will post list of guidance documents for development each year • FDA will accept suggestions for new or different guidances • FDA will provide opportunity for comments or draft language

29. Qualitative Goals Imaging Devices with Contrast Agents or Radiopharmaceuticals • FDA will develop a guidance document on review of these products • FDA will publish guidance by end of FY 2008

30. In Vitro Diagnostics New or Revised Guidance documents on: • Clinical trials involving de-identified leftover specimens • Clinical trial design for molecular diagnostics • Migration studies • Herpes Simplex Virus IVDs • Enterovirus IVDs • Influenza testing

31. In Vitro Diagnostics • Pilot program on review of CLIA waivers and 510(k)s • CLIA waiver study protocols • Tracking review times for CLIA waiver applications • Reviewing list of Class I and Class II low risk IVDs • Pre-IDE review program for IVD devices

32. Pediatric Medical Device Safety and Improvement Act Tracking Pediatric Device Approvals • Pediatric subpopulations described in HDE and PMA applications • Number of pediatric patients affected • Annual Report to Congress

33. Determination of Pediatric Effectiveness • Use of adult data to support approval for pediatric population • Extrapolation of data from one pediatric subpopulation to another

34. Modifications to Humanitarian Device Exemptions • Profit prohibition eliminated for Pediatric HDEs • Annual distribution cannot exceed distribution in the first year • Adverse Events reported to Office of Pediatric Therapeutics • FDA required to issue guidance to IRBs in 180 days • GAO Report assessing impact of HDE profit exemption

35. Encouraging Pediatric and Medical Device Research & Development HHS plan for pediatric device R & D • Plan due in 180 days • Status of federally funded Research • Identification of any gaps • Research agenda for improving development of pediatric devices

36. Demonstration Grants for Improving Pediatric Device Availability • HHS to issue RFPs for demonstration projects in 90 days • Description of how federal funds are to be used

37. Office of Pediatric Therapeutics • Pediatric access to devices added to the role of the Office • Pediatric Advisory Committee to include devices

38. Title VIII Clinical Trials Databases General Requirements • Mandatory registration of applicable device trials in www.Clinicaltrials.gov • Small feasibility trials excluded from definition of applicable trial • Potential retroactivity to trials completed before enactment • Certification of compliance submitted with PMA, HDE, or 510(k)

39. Registry Submission and Posting • Registration applies to trials initiated after enactment or ongoing 90 days after enactment • Posting of registration delayed 30 days after clearance or approval

40. Results Submission and Posting • Results data submitted 1 year after earlier of estimated or actual trial completion • FDA will expand required data to be submitted 1 year post enactment • FDA will promulgate regulations 3 yrs post enactment on expansion of data bank

41. Prohibited Acts and Civil Penalties • Failure to comply or submission of false or misleading information • Establishes strict liability (no intent necessary) • Establishes fines and Civil Money Penalties

42. Postmarket Surveillance • FDA may order 522 study as condition of clearance or approval • For significant use in a pediatric population • FDA may order longer studies for pediatric devices • Allows dispute resolution for orders to conduct 522 studies

43. Title VI Reagan Udall Foundation Foundation • Modernize development of FDA regulated products • Accelerate innovation • Enhance product safety Establishes Foundation Board of Directors

44. Office of Chief Scientist • Established within Office of Commissioner • Responsible for oversight coordination and QA of intramural research at FDA

45. Critical Path Public-Private Partnerships • Collaborative Agreements with eligible entities • Institutions of Higher Education • 501(c)(3) Non Profit Organizations • Funding from regulated industry not permitted

46. Title VII Conflicts of Interest • Advisory Committee member recruitment • Disclosure of financial interest required • Waivers permitted • Reductions in number of waivers over next 5 years

47. Title XI  Other Provisions Improving Genetic Test Safety and Quality • Requires IOM to conduct study to assess quality and safety of genetic tests IF • Secretary’s Advisory Committee on Genetics, Health and Society does not issue report by July 2008