The Accreditation Scheme for Conformity Assessment Program: Draft Guidances for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff; Availability; Extension of Comment Period

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability that appeared in the Federal Register of September 23, 2024. In the notice of availability, FDA requested comments on three draft guidance documents for industry and FDA staff entitled "The Accreditation Scheme for Conformity Assessment (ASCA) Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff"; "Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment--Standards Specific Information for the ASCA Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff"; and "Biocompatibility Testing of Medical Devices--Standards Specific Information for the ASCA Program; Guidance for Industry, Accreditation Bodies, Testing Laboratories, and FDA Staff." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

Abstract as published in the Federal Register.

The complete document — every provision, the docket, and the comment instructions — is published in the Federal Register. SPEQ surfaces and indexes it for reference; the authoritative text lives on federalregister.gov.