Federal Register #FDA-2026-N-7130

FDA Requests Public Comment on ASCA Program Information Collection

This opportunity is a public comment request from the Food and Drug Administration (FDA) regarding the Accreditation Scheme for Conformity Assessment (ASCA) Program. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - Purpose: - FDA seeks public input on information collection for the ASCA Program, which accredits testing laboratories to assess medical device conformity with FDA-recognized standards. - Program Details: - The ASCA Program is voluntary and involves accreditation bodies, testing laboratories, device manufacturers, and FDA staff. - The program aims to streamline and improve the quality and efficiency of medical device regulation. - Requirements: - The notice outlines estimated annual reporting, recordkeeping, and third-party disclosure burdens for participants. - No procurement of products or services is requested. - OEMs and Vendors: - No specific OEMs, vendors, or part numbers are mentioned, as this is not a procurement action. - Unique Aspects: - Focus is on information collection and program participation requirements, not on purchasing goods or services.

Description

The Food and Drug Administration (FDA) is seeking public comments on the proposed collection of information related to the Accreditation Scheme for Conformity Assessment (ASCA) Program. The ASCA Program is a voluntary pilot program under which testing laboratories may be accredited to assess the conformance of medical devices with FDA-recognized standards. Accredited testing laboratories provide determinations that FDA generally accepts for demonstrating conformity, which supports premarket submissions. The program involves accreditation bodies, testing laboratories, device manufacturers, and FDA staff, and aims to promote quality and efficiency in medical device regulation. Comments on the information collection are due by September 15, 2026.

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