FDLI Introduction to Medical Device Law and Regulation

1. FDLI Introduction to Medical Device Law and Regulation Other Postmarket Controls Philip Katz(202) 624-2660pkatz@crowell.com October 29, 2002Washington, D.C.

2. Device Tracking • FDCA § 519(e) • 21 CFR Part 821 (amended effective May 9, 2002) • “Guidance on Medical Device Tracking” (Jan. 2000)

3. FDCA § 519(e) • Class II or III device • Failure likely to have serious adverse health consequences • Intended to be implanted for more than one year • Life sustaining/supporting device used outside device user facility

4. Additional Factors • Likelihood of sudden, catastrophic failure • Likelihood of significant adverse clinical outcome • Need for prompt professional intervention

5. Device Tracking • To ensure that device can be traced from manufacturing facility to patient • Must be able to locate device quickly • Three days for undistributed device • Ten days for device distributed to patient

6. Device Tracking • Separate order issued with PMA approval or 510(k) clearance • Methods may vary, but must have written SOPs • Can use outside contractor

7. Device Tracking • Must audit system, to verify that it works and the information is accurate • Must maintain records as long as device is in distribution or use

8. Device Tracking • Distributors (such as hospitals and other user facilities) must track and provide information to the manufacturer • Obligations start/stop at water’s edge • Patient can refuse identifying information

9. Postmarket Surveillance • FDCA § 522 • 21 CFR Part 822 (effective July 8, 2002) • “Guidance on Criteria and Approaches for Postmarket Surveillance” (Nov. 1998)

10. FDCA § 522 • Class II or III device • Failure likely to have serious adverse health consequences • Intended to be implanted for more than one year • Life sustaining/supporting device used outside device user facility

11. Other Criteria • Important unanswered surveillance question • Availability of other postmarket mechanisms • Practicality of surveillance strategies • Magnitude of risk

12. Postmarket Surveillance • Limitations of premarket data • Shortcomings of MDRs

13. Postmarket Surveillance • Required by FDA order, not necessarily at time of review/clearance • Manufacturer must submit plan in 30 days • FDA has 60 days to judge plan’s adequacy

14. Range of Methods • Literature review • Secondary data sets, registries • Studies (clinical, non-clinical)

15. Postmarket Surveillance • Can last up to three years • Applies to foreign manufacturers • Does not apply to devices for export only • Informed consent and IRB requirements apply

16. Postmarket Surveillance • Interim and final reports • Retain records for two years • Produce records within three days • Records subject to inspection/review

17. Device Promotion • Advertising • Not defined, but see drug regulations • Labeling • Label and “all other written, printed or graphic matter . . . accompanying” the device

18. Device Promotion • Misleading • FDCA § 201(n) • Not just representations made or suggested, but also material omissions

19. FDCA § 502 – Misbranding • All devices • False or misleading labeling (FDCA § 502(a)) • Adequate directions for use, adequate warnings (FDCA § 502(f)) • Registration, listing, 510(f) notice/information (FDCA § 502(o))

20. FDCA § 502 – Misbranding • Restricted devices • False or misleading advertising (FDCA § 502(q)) • Advertising or “other descriptive matter” lacks side effects, contraindications (FDCA § 502(r))

21. Device Promotion • Unapproved uses • False or misleading statements

22. Unapproved Uses • Promotion of device that is not approved or cleared • Promotion of cleared/approved device for use that is not cleared or approved • Not limited to advertising/labeling

23. False or Misleading Statements • Shared jurisdiction • FDA – all labeling, restricted device ads • FTC – all other device ads • Sort of

24. False or Misleading Statements • Jurisdiction makes a difference • Different outlooks • Different processes • Different results

25. False or Misleading Statements • FDA • No clear standard • Can look to drug ad regulations • Can look to FTC

26. False or Misleading Statements • FTC • Identifying the representation • Determine whether it’s true and substantiated

27. FTC • Identify the representation • Express and implied claims • Intent irrelevant • Reasonable interpretation by target audience

28. FTC • Is the claim true and substantiated? • Implied presence of substantiation • “Establishment” claims • True + false = false

29. Other Issues • Internet • First Amendment

30. FDLI Introduction to Medical Device Law and Regulation Other Postmarket Controls Philip Katz(202) 624-2660pkatz@crowell.com October 29, 2002Washington, D.C.