1. 510(k) Process: Best Practices in Changing Times… MassMEDIC Massachusetts Medical Society, Waltham, MA April 1, 2010 8:00 AM - 10:30 AM

2. 2 510(k) Process Best Practices in Changing Times Welcome: Tom Sommer MassDevice ( www.massdevice.com ) www.massdevice.com Overview of the 510(k) Process: Rosina Robinson, MDCI 510(k) Pathways: Terry Sullivan, Gyrus/ACMI 510(k) Submissions to CBER: Sue Finneran, Haemonetics Corp. FDA/Congressional Update on Plans for 510(k) Program - Paul Kim, Foley Hoag

3. 3 Breaking news from CNN at 7:45 AM… CDRH plans to rescind clearance of all premarket notifications for all currently marketed Class II and III devices and will require resubmission of information according to new requirements to be defined later today…

4. 4 Breaking news… April Fool

5. 5 510(k) Process: Best Practices in Changing Times "The only things certain in life are death and taxes.” Benjamin Franklin

6. 6 510(k)s: Why are we here today? Questionable rigor of the 510(k) process and effectiveness of regulation of the industry has created an environment of uncertainty.  Failure of FDA to take final classification action on all pre- amendment Class III devices currently cleared by 510(k) – Manufacturers of final group of devices required to submit data summer 2009  Perceived conflict of interest created by industry payment of review user fees to the FDA  Alleged coercion of review staff  Questionable quality of 3 rd party review program What’s next?  Creation of internal task force  IOM investigation with report due March 2011

7. 7 What is a medical device? Per Chapter 2, §201(h) of Food, Drug, and Cosmetic Act, as amended: A medical device is an instrument, apparatus, implement, machine, contrivance, implant, or in vitro reagent Intended to:  Diagnose diseases/conditions;  Cure, mitigate, treat, or prevent disease;  Affect the structure/function of the human body; and … Does not achieve primary purpose through chemical action in or on the body. Is not dependent upon being metabolized for its primary purpose.

8. 8 510(k) – Statutory Basis SEC. 510. [21 USC §360] Registration of Producers of Drugs and Devices  Report preceding introduction of devices into interstate commerce.  Persons required to register who proposes to introduce device for human use into interstate shall report at least ninety days before  (1) the class in which the device is classified under section 513; If not classified, a statement of that determination and the basis for the determination and  (2) action taken by such person to comply with requirements under section 514 or 515 which are applicable to the device.  …

9. 9 510(k) – Regulations 21 CFR 807.90 Format of a premarket notification  42 FR 4256, August 23, 1977, as amended at 53 FR 11252 April 6, 1988  55 FR 11169, March 27, 1990  65 FR 17137, March 31, 2000  70 FR 14986, March 24, 2005

10. 10 510(k) – Regulations 21 CFR 807.92 Content and format of a 510(k) summary  57 FR 18066, April 28, 1992, as amended at 59 FR 64295, December 14, 1994 21 CFR 807.93 Content and format of a 510(k) statement  59 FR 64295, December 14, 1994 21 CFR 807.94  59 FR 64296, December 14, 1994 …

11. 11 510(k)s – “Guidance” Guidance document database (includes Special Controls)  http://www.fda.gov/MedicalDevices/DeviceReg ulationandGuidance/GuidanceDocuments/defa ult.htm http://www.fda.gov/MedicalDevices/DeviceReg ulationandGuidance/GuidanceDocuments/defa ult.htm Standards database  http://www.fda.gov/MedicalDevices/DeviceReg ulationandGuidance/Standards/default.htm http://www.fda.gov/MedicalDevices/DeviceReg ulationandGuidance/Standards/default.htm

12. 12 Center for Devices and Radiological Health (CDRH) PRIMARY CENTER & CPs Center for Devices and Radiological Health (CDRH) PRIMARY CENTER & CPs FDA Centers with Product Review and Compliance Responsibilities (CP=Combination products) FDA Centers with Product Review and Compliance Responsibilities (CP=Combination products) Center for Food Safety and Applied Nutrition (CFSAN) Center for Veterinary Medicine (CVM) Center for Drug Evaluation and Research (CDER) CPs CPs Center for Biologics Evaluation and Research (CBER) DESIGNATED DEVICES & CPs Center for Biologics Evaluation and Research (CBER) DESIGNATED DEVICES & CPs FDA oversight for medical devices authorized by 1976 Medical Device Amendments of 1976 (§513, FD&C Act, as amended)

13. 13 510(k)s - The Past Class I  Exempt from pre-market notification Class II  510(k) premarket notification Class III  Class III 510(k) for pre- amendment devices for which PMAs have not yet been announced Relative regulatory burden

14. 14 510(k)s – Key Changes Then: Simple notification to the FDA of planned marketing 90 days before introduction of the device into interstate commerce  Now: Prohibition from marketing without explicit written clearance THEN: Regulatory information limited to information requested under FOI.  NOW: Enforcement of 510(k) Summary content or compliance with 510(k) Statement obligations.  FUTURE?: Change to on-line 510(k) database to allow easier identification of predicate/s.

15. 15 510(k)s – Key Changes… THEN: Only the FDA can review 510(k)s.  NOW: Use of Accredited Persons for 510(k) review (except for those including clinical data)  FUTURE?: Elimination of program? THEN: No Medical Device User Fee  NOW: Medical Device User Fees for review of premarket submissions for medical devices (with Small Business reductions or Third Party review)

16. 16 510(k)s - The Present Class I  Exempt from pre-market notification unless specifically reserved Class II  510(k) premarket notification -Traditional, Abbreviated, or Special unless specifically exempt – may include clinical data (March 1998)  510(k)s cleared in FY2008: 3,058 (2 by DeNovo; 23 with clinical trials; FY 2009, 250 by third party review) Class III 510(k)s:  Preamendment Class III devices for which premarket approval applications have not been announced – Now but maybe not for long… Relative regulatory burden

17. 17 510(k)s - The Present

18. 18 510(k)s - The Future Class I  Exempt from pre-market notification unless specifically reserved Class II  510(k) premarket notification - Traditional, Abbreviated, or Special unless specifically exempt – may include clinical data (March 1998) Class III - NO 510(k) Relative regulatory burden

19. 19 510(k)s – The Future Buzzwords at February 9 and February 18 FDA public meetings:  Transparency  Predictability  Adaptability Can industry expect the CDRH to meet these goals? What will it take? Has the integrity and usefulness of the current pre-IDE process been compromised?

20. 20 510(k)s – The Past – What about the future? Pre-IDE process  Potential Benefits  More formal than isolated telephone call or email  Establishes point/s of contact with review staff  Can identify Agency concerns before submission/s made

21. 21 510(k)s – The Past – What about the future? Pre-IDE process…  Limitations:  Minimizes but does not always prevent later surprises  Does not provide an in-depth review or formal Agency commitment to final requirements or acceptance  Things change…

22. 22 510(k) Process: Best Practices in Changing Times What can we do to address today’s and future uncertainty?  Take a step back and return to the basics  Share ideas with colleagues  Stay current with rapidly changing environment

23. 23 510(k)s: Preview of things to come? FDA March 23, 2010 Meeting of the Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee. Advisory Panel for reevaluation of the ReGen Collagen Scaffold (CS) device http://www.foxbusiness.com/story/markets/i ndustries/technology/update-fdanot-data- regen-knee-device-safe/ http://www.foxbusiness.com/story/markets/i ndustries/technology/update-fdanot-data- regen-knee-device-safe/

24. 24 510(k)s: What will the future bring? http://web.ics.purdue.edu/~ssanty/cgi-bin/eightball.cgi

25. 25 510(k)s: The last word “The only certainty is that nothing is certain.” Pliney, the Elder

26. 26 510(k) Process: Best Practices in Changing Times Welcome: Tom Sommer MassDevice Overview of the 510(k) Process: Rosina Robinson, MDCI (robinson@mdci.com) 510(k) Pathways: Terry Sullivan, Gyrus/ACMI 510(k) Submissions to CBER: Sue Finneran, Haemonetics Corp. FDA/Congressional Update on Plans for 510(k) Program - Paul Kim, Foley Hoag