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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.

U.S. Food and Drug Administration
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  3. Device Advice: Comprehensive Regulatory Assistance
  4. How to Study and Market Your Device
  5. Premarket Submissions: Selecting and Preparing the Correct Submission
  6. Division of Standards and Conformity Assessment
  7. ASCA-Accredited Testing Laboratories
  1. Division of Standards and Conformity Assessment

ASCA-Accredited Testing Laboratories

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-accredited testing laboratories and their respective scopes of accreditation.

Notes:

  • Testing laboratories who wish to participate in ASCA should demonstrate that they have been accredited by an ASCA-recognized accreditation body to the currently FDA-recognized versions of the standards and test methods included in ASCA. Please check the Recognized Consensus Standards database for the currently recognized versions.
  • 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.
  • As of January 3,2024, Bay Area Compliance Lab has been withdrawn from the ASCA program.
  • ASCA-Accredited Testing Laboratories (fda.gov)
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