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FDA Provides Update on ASCA Testing Laboratory Accreditation

The U.S. Food and Drug Administration (FDA) says it will release within the next 45 days an initial list of accredited testing laboratories under its Accreditation Scheme for Conformity Assessment (ASCA) pilot program.

As we’ve previously reported, the ASCA pilot accreditation program will allow 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.

According to an announcement posted on the FDA website earlier this month, the list of accredited laboratories for the ASCA pilot program will be published by April 12th, with additional laboratories added to the list as they become accredited. Laboratories must complete a two-step process to become ASCA-accredited, which includes: 1) accreditation for conformity with the requirements of ISO/IEC 17025 and additional ASCA pilot program specifications; and 2) submit a request to the FDA to obtain ACSA-accreditation.

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Get up-to-date information on the ASCA pilot program, as well as access to ASCA-specific guidances and webinars.

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