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