Medical Devices; Quality System Regulation Amendments; Correction
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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 or Agency) is correcting a final rule that appeared in the Federal Register on February 2, 2024. In that final rule, FDA amended the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the device CGMP. FDA is correcting an editorial error that inadvertently omitted a definition in the codified of the final rule. This action is editorial in nature and is intended to ensure the accuracy and clarity of the Agency's regulations.
Abstract as published in the Federal Register.
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