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Benefit-Risk Determinations for Medical Device Premarket Review

This guidance explains the principal factors that FDA considers when making benefit-risk determinations in the premarket review of medical devices subject to premarket approval (PMA) applications or De Novo classification requests. It applies to both diagnostic and therapeutic devices, and the concepts are applicable throughout the medical device development process from design to market.

  1. Document and assess the extent of probable benefits including:
    • Type of benefits
    • Magnitude of benefits
    • Probability of experiencing benefits
    • Duration of effects
  2. Document and assess the extent of probable risks including:
    • Severity and types of harmful events
    • Probability of harmful events
    • Duration of harmful events
    • Risks from false results for diagnostics
  3. Consider additional factors in benefit-risk assessment:
    • Characterize uncertainty in benefits and risks
    • Evaluate patient perspectives and preferences
    • Assess available alternatives
    • Identify risk mitigation strategies
    • Consider postmarket data needs
  4. Use the provided worksheet to document benefit-risk determinations systematically
  5. Ensure transparency in benefit-risk decisions through clear documentation
  6. Consider early interaction with FDA review division when developing patient preference data
  7. For novel technologies, assess if greater uncertainty may be acceptable given unmet medical need
  8. Document risk management decisions according to ISO 14971 requirements
  9. Consider postmarket studies when appropriate to further characterize benefits and risks
  10. Ensure labeling clearly communicates benefits and risks to users

Key Considerations

Clinical testing

  • Clinical testing methods can include randomized clinical trials, well-controlled investigations, partially controlled studies, case histories, and testing on clinical specimens
  • Both clinical and non-clinical data play important roles in benefit-risk determinations
  • FDA relies on valid scientific evidence in making risk and benefit determinations

Non-clinical testing

  • Can include performance testing for safety/reliability/characterization, human factors testing, animal studies, computer simulations
  • Tests mechanical, electrical and chemical properties including wear, strength, biocompatibility, EMC, sterility, stability, software validation
  • Non-clinical data can be critical for understanding device safety and effectiveness

Safety

  • FDA assesses severity, types, number and rates of harmful events
  • Considers device-related serious and non-serious adverse events
  • Evaluates procedure-related complications
  • Assesses probability and duration of harmful events
  • For diagnostics, considers risks from false positives/negatives

Other considerations

  • ISO 14971: Medical devices - Application of risk management to medical devices

Original guidance

  • Benefit-Risk Determinations for Medical Device Premarket Review
  • HTML / PDF
  • Issue date: 2019-08-30
  • Last changed date: 2020-10-20
  • Status: FINAL
  • Official FDA topics: Medical Devices, Premarket, Premarket Approval (PMA), Biologics
  • ReguVirta summary file ID: 5c23a5a2caf7cf0ceb4b365c7da83162
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