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FDLI Introduction to Medical Device Law and Regulation Other Postmarket Controls Philip Katz (202) 624-2660 [email protected] October 29, 2002 Washington, D.C. Device Tracking FDCA § 519(e) 21 CFR Part 821 (amended effective May 9, 2002) “Guidance on Medical Device Tracking” (Jan. 2000) 2 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 3 Additional Factors Likelihood of sudden, catastrophic failure Likelihood of significant adverse clinical outcome Need for prompt professional intervention 4 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 5 Device Tracking Separate order issued with PMA approval or 510(k) clearance Methods may vary, but must have written SOPs Can use outside contractor 6 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 7 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 8 Postmarket Surveillance FDCA § 522 21 CFR Part 822 (effective July 8, 2002) “Guidance on Criteria and Approaches for Postmarket Surveillance” (Nov. 1998) 9 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 10 Other Criteria Important unanswered surveillance question Availability of other postmarket mechanisms Practicality of surveillance strategies Magnitude of risk 11 Postmarket Surveillance Limitations of premarket data Shortcomings of MDRs 12 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 13 Range of Methods Literature review Secondary data sets, registries Studies (clinical, non-clinical) 14 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 15 Postmarket Surveillance Interim and final reports Retain records for two years Produce records within three days Records subject to inspection/review 16 Device Promotion Advertising Not defined, but see drug regulations Labeling Label and “all other written, printed or graphic matter . . . accompanying” the device 17 Device Promotion Misleading FDCA § 201(n) Not just representations made or suggested, but also material omissions 18 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)) 19 FDCA § 502 – Misbranding Restricted devices False or misleading advertising (FDCA § 502(q)) Advertising or “other descriptive matter” lacks side effects, contraindications (FDCA § 502(r)) 20 Device Promotion Unapproved uses False or misleading statements 21 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 22 False or Misleading Statements Shared jurisdiction FDA – all labeling, restricted device ads FTC – all other device ads Sort of 23 False or Misleading Statements Jurisdiction makes a difference Different outlooks Different processes Different results 24 False or Misleading Statements FDA No clear standard Can look to drug ad regulations Can look to FTC 25 False or Misleading Statements FTC Identifying the representation Determine whether it’s true and substantiated 26 FTC Identify the representation Express and implied claims Intent irrelevant Reasonable interpretation by target audience 27 FTC Is the claim true and substantiated? Implied presence of substantiation “Establishment” claims True + false = false 28 Other Issues Internet First Amendment 29 FDLI Introduction to Medical Device Law and Regulation Other Postmarket Controls Philip Katz (202) 624-2660 [email protected] October 29, 2002 Washington, D.C.