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Safer Technologies Program for Medical Devices and Device-Led Combination Products with Enhanced Safety Benefits

This guidance introduces the Safer Technologies Program (STeP), a voluntary program for medical devices and device-led combination products that are expected to significantly improve safety compared to currently available treatments or diagnostics. The program focuses on devices targeting conditions less serious than those eligible for the Breakthrough Devices Program, while being subject to PMA, De Novo, or 510(k) review pathways.

  1. Evaluate eligibility for STeP program based on general and specific factors
  2. Submit Q-submission request for program inclusion before marketing submission
  3. Prepare comprehensive device description and safety improvement justification
  4. Plan early engagement with FDA through available mechanisms (Sprint, DDP)
  5. Develop clear safety improvement metrics and evaluation strategy
  6. Consider both pre and post-market data collection strategies
  7. Prepare for interactive review process with FDA
  8. Establish regular status update schedule with FDA
  9. Document all safety innovations and their expected benefits
  10. Plan manufacturing quality system compliance for PMA submissions

Key Considerations

Clinical testing

  • Clinical data may be needed to support safety improvement claims
  • Efficient and flexible clinical study designs may be considered
  • Real-world data sources may be used to support proposed indications

Non-clinical testing

  • Early discussion of non-clinical testing requirements is encouraged
  • Testing should be planned early in development process
  • Proposals should be discussed with FDA

Human Factors

  • Use-related hazards and errors should be addressed through device design
  • Focus on reducing use-related hazards associated with design/operational features
  • Not focused on labeling-related hazards

Labelling

  • Should include specific claims related to safety improvement if planned
  • Must meet applicable statutory standards
  • Should clearly describe intended use and safety benefits

Safety

  • Must demonstrate significant improvement in benefit-risk profile
  • Should address one of four safety improvement categories:
    • Reduction in known serious adverse events
    • Reduction in known device failure modes
    • Reduction in known use-related hazards
    • Improvement in safety of another device/intervention
  • Safety improvements should not compromise effectiveness

Other considerations

  • IEC 60812: Analysis techniques for system reliability – Procedure for failure mode and effects analysis (FMEA)
  • ISO 14971: Medical devices – Applications of risk management to medical devices

Original guidance

  • Safer Technologies Program for Medical Devices and Device-Led Combination Products with Enhanced Safety Benefits
  • HTML / PDF
  • Issue date: 2021-01-06
  • Last changed date: 2021-01-07
  • Status: FINAL
  • Official FDA topics: Medical Devices, 510(k), Premarket, Premarket Approval (PMA)
  • ReguVirta summary file ID: 0afe04546cbffeb634566e4d7f2ad442
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