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Balancing Pre-Market and Post-Market Data Collection for PMA Medical Devices

This guidance clarifies FDA's policy on balancing premarket and postmarket data collection during FDA review of premarket approval applications (PMAs). It outlines how FDA considers postmarket information in determining the extent of data needed in the premarket setting while still meeting the statutory standard of reasonable assurance of safety and effectiveness.

  1. Evaluate if device qualifies for postmarket data collection based on maturity of technology, public health need, or other factors
  2. Submit Pre-Submission to discuss potential postmarket data collection strategy with FDA
  3. Design appropriate post-approval study protocol considering:
    • Sample size requirements
    • Market conditions
    • Recruitment challenges
    • Risk level of device
  4. Develop labeling that clearly describes uncertainties and data limitations
  5. Establish processes to:
    • Monitor and report postmarket data
    • Implement labeling changes if needed
    • Track post-approval study progress
    • Meet periodic reporting requirements
  6. Create contingency plans for potential postmarket actions including:
    • PMA supplements
    • Labeling updates
    • Safety communications
    • Regulatory responses
  7. Maintain documentation of compliance with post-approval requirements

Key Considerations

Clinical testing

  • Clinical data collection can be shifted to postmarket setting for mature technologies with well-understood benefits and risks
  • Post-approval studies may be appropriate to confirm mitigation effectiveness for known risks
  • Long-term performance assessment may be conducted postmarket
  • Rare adverse events may be evaluated postmarket when FDA has low uncertainty about benefit-risk balance
  • Clinical confirmation of bench data may be collected postmarket

Non-clinical testing

  • Non-clinical testing may be conducted postmarket to confirm bench data
  • Long-term mechanical testing may be deferred to postmarket for well-understood device types

Labeling

  • Labeling must include description of uncertainty about benefits/risks and extent of data supporting approval
  • Labeling changes may be required based on postmarket data
  • FDA may impose labeling requirements as condition of approval

Safety

  • Safety data collection may be shifted postmarket for mature technologies
  • Rare safety events may be evaluated postmarket
  • Post-approval studies may be required to assess long-term safety

Other considerations

  • 21 CFR 814: Premarket Approval of Medical Devices
  • 21 CFR 822: Postmarket Surveillance
  • 21 CFR 860: Medical Device Classification Procedures

Original guidance

  • Balancing Pre-Market and Post-Market Data Collection for PMA Medical Devices
  • HTML / PDF
  • Issue date: 2015-04-13
  • Last changed date: 2020-10-20
  • Status: FINAL
  • Official FDA topics: Medical Devices, Postmarket, Premarket Approval (PMA), Premarket, Biologics
  • ReguVirta summary file ID: 37ad1d8b7e7a21412be2a7ecd43fa350
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