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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  7. ASCA-Recognized Accreditation Bodies
  1. Division of Standards and Conformity Assessment

ASCA-Recognized Accreditation Bodies

Update: September 20, 2024

On September 20, 2024, the FDA issued the following draft guidances:

These guidances include updates to the ASCA program based on feedback from public meetings, webinars, stakeholder meetings, and lessons learned internally during the pilot phase.
 
When final, these guidances will replace the three ASCA Pilot guidances published September 25, 2020.

The link below lists ASCA-recognized accreditation bodies and their respective scopes of recognition.

Note: Some FDA-recognized consensus standards included in ASCA have an identical U.S. adoption (for example, IEC 60601-2-47, ANSI/AAMI/IEC 60601-2-47). For the standards included in ASCA the identical U.S. adoptions to ISO and IEC standards will also be accepted.

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