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_at_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 waters 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 plans 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 its 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

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FDLI Introduction to Medical Device Law and
Regulation

• Other Postmarket Controls

Philip Katz(202) 624-2660pkatz_at_crowell.com
October 29, 2002Washington, D.C.