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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
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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)
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Class II or III device
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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
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Likelihood of sudden, catastrophic failure
Likelihood of significant adverse clinical outcome
Need for prompt professional intervention
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Device Tracking
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To ensure that device can be traced from
manufacturing facility to patient
Must be able to locate device quickly
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Three days for undistributed device
Ten days for device distributed to patient
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Device Tracking
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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
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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
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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
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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
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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
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Important unanswered surveillance question
Availability of other postmarket mechanisms
Practicality of surveillance strategies
Magnitude of risk
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Postmarket Surveillance
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Limitations of premarket data
Shortcomings of MDRs
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Postmarket Surveillance
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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
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Literature review
Secondary data sets, registries
Studies (clinical, non-clinical)
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Postmarket Surveillance
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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
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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
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Advertising
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Not defined, but see drug regulations
Labeling
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Label and “all other written, printed or graphic
matter . . . accompanying” the device
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Device Promotion
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Misleading
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FDCA § 201(n)
Not just representations made or suggested, but also
material omissions
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FDCA § 502 – Misbranding
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All devices
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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
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Restricted devices
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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
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Unapproved uses
False or misleading statements
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Unapproved Uses
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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
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Shared jurisdiction
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FDA – all labeling, restricted device ads
FTC – all other device ads
Sort of
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False or Misleading Statements
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Jurisdiction makes a difference
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Different outlooks
Different processes
Different results
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False or Misleading Statements
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FDA
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No clear standard
Can look to drug ad regulations
Can look to FTC
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False or Misleading Statements
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FTC
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Identifying the representation
Determine whether it’s true and substantiated
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FTC
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Identify the representation
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Express and implied claims
Intent irrelevant
Reasonable interpretation by target audience
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FTC
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Is the claim true and substantiated?
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Implied presence of substantiation
“Establishment” claims
True + false = false
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Other Issues
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Internet
First Amendment
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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.