FDA Authorizes 50+ Testing Labs for Conformity Testing Pilot

The U.S. Food and Drug Administration (FDA) has now accredited more than 50 testing laboratories to participate in its voluntary Accreditation Scheme for Conformity Assessment (ASCA) pilot accreditation program.

As we’ve previously reported, the ASCA pilot program allows accredited independent testing laboratories to assess medical devices for compliance with certain FDA-recognized standards. The establishment of the ASCA was mandated under the 2017 FDA Reauthorization Act and is expected to help facilitate a more efficient review process for certain types of medical devices.

As of this writing, 53 testing laboratories located throughout the U.S. and in Canada, Japan, Germany, Israel, South Korea, and China are now authorized to conduct testing to one or more FDA-recognized versions of standards and test methods included under the scope of the ASCA pilot. The FDA is expected to continue to review and accredit additional testing laboratories and expand laboratory accreditations to include additional recognized standards during the pilot program.

Read the complete list of laboratories accredited to conduct testing under the FDA’s ASCA pilot program.

Read additional information on the pilot program and access ASCA-specific guidances and webinars.

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