Health and Human Services Department Docket FDA-2022-D-0370 Proposed Rule

2022-09232: The Accredited Third-Party Certification Program: Questions and Answers; Draft Guidance for Industry; Availability

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Summary

The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of a draft guidance for industry entitled "The Accredited Third-Party Certification Program: Questions and Answers." The draft guidance, when finalized, will answer frequently asked questions relating to the requirements of the Accredited Third- Party Certification Program, and is intended to assist accreditation bodies', third-party certification bodies', and eligible entities' understanding of the regulation and program requirements.

The agency’s own summary, as published.

What this changes

Amends 1 part of the Code of Federal Regulations — the standing rules this notice rewrites.

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