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FDA Issues Guidance Documents on Pilot Accreditation Scheme

The U.S. Food and Drug Administration (FDA) has issued three final guidance documents in support of a pilot program that would allow accredited testing laboratories to assess medical devices for compliance with certain FDA-recognized standards.

The three final guidance documents issued by the FDA include:

  • “The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program”—This guidance describes how the Pilot accreditation program was designed and how accreditation bodies, testing laboratories and device manufacturers can participate in the program.
  • “Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program”—This guidance provides information specific to the basic safety and essential performance of standards in the Pilot program. Specifically, the guidance addresses which standards are eligible for inclusion in the Pilot, ASCA program specifications for those standards, and recommended premarket submission contents specific to those standards when testing is conducted by an ASCA-accredited testing laboratory.
  • “Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program—This guidance provides information on the biological evaluation of medical device standards and test methods in the ASCA Pilot. Similar to the previously referenced guidance, this guidance discusses the standards and test methods eligible for inclusion in the program, program specifications for those standards, and recommended contents specific to those standards.

Read the full text of the FDA’s notice regarding the release of these guidance documents as published in the Federal Register.

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Required under the 2017 FDA Reauthorization Act, the FDA’s pilot accreditation program would help to facilitate a more efficient review process for certain types of medical devices, allowing device manufacturers to bring new and innovated products to market more quickly.

The FDA will also conduct a webinar for the medical device industry and other interested participants on October 22nd to discuss and answer questions about the three final guidance documents. Read additional information about the webinar, along with links to each of the individual guidance documents.

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