Benefit-Risk Factors in Medical Device Product Availability, Compliance, and Enforcement Decisions

Recommended Actions

1. Document benefit assessment considering:
   • Type and magnitude of benefits
   • Likelihood of patients experiencing benefits
   • Duration of effects
   • Patient perspective
   • Medical necessity
2. Document risk assessment considering:
   • Severity of harm
   • Likelihood of risk
   • Distribution of nonconforming devices
   • Duration of exposure
   • Patient tolerance
   • Detectability
3. Evaluate additional factors:
   • Uncertainty level
   • Available mitigations
   • Failure modes
   • Scope of issues
   • Patient impact
   • Firm compliance history
4. Consider using provided worksheets in appendices for structured benefit-risk assessment
5. Implement appropriate mitigation strategies based on benefit-risk assessment outcome
6. Monitor effectiveness of decisions and update assessments as new information becomes available
7. Maintain documentation of benefit-risk assessments and decision rationale

Key Considerations

Human Factors

• Consider patient perspective on benefits and risks
• Evaluate patient tolerance for risk
• Assess healthcare professional/caregiver benefits and risks

Labelling

• Consider labeling changes as potential mitigation strategy
• Evaluate if benefits and risks are adequately communicated in labeling

Safety

• Assess severity of harm (deaths, serious injuries, non-serious adverse events)
• Evaluate likelihood of risk
• Consider duration of exposure to population
• Analyze failure modes
• Assess detectability of issues
• Consider distribution of nonconforming devices

Other considerations

• Evaluate medical necessity of device
• Consider availability of alternative treatments
• Assess uncertainty in benefit-risk determination
• Review firm compliance history
• Evaluate scope of device issues
• Consider patient impact if device is/isn’t available
• Assess nature of violations/nonconforming product

  Relevant Guidances

• Use of ISO 10993-1 for Biological Evaluation and Testing of Medical Devices
• Benefit-Risk Determinations for Medical Device Premarket Review
• Benefit-Risk Assessment with Uncertainty in Medical Device Premarket Submissions

Related references and norms

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

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Original guidance

• Benefit-Risk Factors in Medical Device Product Availability, Compliance, and Enforcement Decisions
• HTML / PDF
• Issue date: 2016-12-27
• Last changed date: 2019-03-04
• Status: FINAL
• Official FDA topics: Safety - Issues, Adverse Event Reporting System (FAERS), Laser Notice, Medical Devices, Errors, Postmarket, Adverse Event Reporting, Premarket Approval (PMA), and Problems, 510(k), Combination Products, HUD/HDE, Investigational Device Exemption (IDE), Recalls
• ReguVirta summary file ID: 87dc4fdd62d68b5545e53c45a82947d5