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    FDA Recognized Consensus Standards

    Voluntary standards that FDA has formally recognized for use in establishing device conformity.

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

    Definition

    FDA's Recognized Consensus Standards database lists ISO, IEC, ASTM, AAMI, and other standards that sponsors can declare conformity to via a Standards Data Report, simplifying review of the corresponding submission elements.

    What this means in practice

    Choosing recognized standards (and citing the recognition number) is the cleanest way to streamline 510(k) and De Novo reviews.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    FDA·2RAPS·1
    1. 1
      FDA Standards Database
      Verified
      FDAaccessdata.fda.gov
    2. 2
      RAPS Regulatory Focus
      Verified
      RAPSraps.org
    3. 3
      FDA - Medical Devices
      Verified
      FDAfda.gov

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