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Medical Devices / Regulatory Affairs

FDA Pilots Accreditation Scheme for Conformity Assessment

Oct. 9, 2019

The FDA is establishing a pilot accreditation scheme for conformity assessment (ASCA) whereby testing laboratories may be accredited by accreditation bodies to assess the conformance of a device with certain FDA-recognized standards.

The agency is proposing to accept in-house testing laboratories as participants in the ASCA pilot.

An accredited testing lab may conduct testing to determine conformance of a device with at least one of the standards eligible for inclusion in the ASCA pilot.

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