Comments on the Proposed Rule: Medical Devices; Quality System Regulation Amendments Share page: Docket Number: FDA–2021–N–0507 Download Document Issues: OTC Medical Devices Other Issues Quality Related Posts 2025 Mid-Year Impact Report Jun 20, 2025 Letter Letter Regarding Office of Management & Budget Request for Information: Deregulation May 12, 2025 Press Releases and Statements Veteran Scientist & Regulator Joins CHPA’s Senior Management Team May 12, 2025