Medical Devices; Quality Management System Regulation Technical Amendments
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA, the Agency, or we) is amending certain medical device regulations to revise references and language in existing Code of Federal Regulations (CFR) provisions to conform with the final rule "Medical Devices; Quality System Regulation Amendments" (QMSR Final Rule). This rule does not impose any new requirements on affected parties. This action is editorial in nature to correct errors, conform regulatory references, and ensure accuracy and clarity in the Agency's regulations.
Abstract as published in the Federal Register.
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