Business · 08/10/1998Updated: 10/17/2026 · 1 min read

FDA Amends Regulations for Medical Devices; 30-Day Notices and 135-Day PMA Supplement Review

The FDA is updating its rules for submitting and reviewing premarket approval supplements for medical devices, requiring a 30-day notice for changes to manufacturing procedures or methods, as part of revisions to the Federal Food, Drug, and Cosmetic Act implemented by the Food and Drug Administration Modernization Act of 1997.