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FDA Expands Efforts to Accredit Testing Laboratories Under ASCA Pilot Program

The U.S. Food and Drug Administration (FDA) is ramping up its efforts to expand the use of its voluntary Accreditation Scheme for Conformity Assessment (ASCA) Pilot, a program intended to more effectively leverage widely accepted industry standards in the review and approval of medical device submissions.

The ASCA pilot accreditation program allows device manufacturers to use 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.

To become accredited under the ASCA pilot program, testing laboratories must complete a two-step process, which includes: 1) accreditation for conformity with the requirements of ISO/IEC 17025 and additional ASCA pilot program specifications; and 2) submission of a request to the FDA to obtain ACSA-accreditation.

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Read general information about the FDA’s ASCA Pilot program.

Read information about the accreditation of testing laboratories under the ASCA Pilot program.

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