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    Safer Technologies Program

    FDA program for devices addressing less serious conditions but offering meaningful safety improvements.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    STeP provides Breakthrough-style benefits - interactive review and prioritization - for devices reasonably expected to significantly improve the safety of currently available treatments or diagnostics for non-life-threatening conditions.

    What this means in practice

    Often used for safer redesigns of existing devices (e.g., reducing infection risk, eliminating a hazardous material). Acceptance is selective.

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    FDA·2European Commission·1
    1. 1
      Safer Technologies Program (STeP)
      Bot-blocked
      FDAfda.gov
    2. 2
      FDA - Medical Devices
      Verified
      FDAfda.gov
    3. 3
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu

    Inline markers like [1] jump to the matching reference above.