Medical Devices; 30-Day Notices and 135-Day PMA Supplement Review; Companion Document to Direct Final Rule

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The Food and Drug Administration (FDA) is proposing to amend its regulations governing the submission and review of premarket approval application (PMA) supplements to allow for the submission of a 30-day notice for modifications to manufacturing procedures or methods of manufacture. Amendments are being made to implement revisions to the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Food and Drug Administration Modernization Act of 1997 (FDAMA). This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.