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 Press Releases and Statements Health In Hand Foundation Announces Call for Nominations: 2025 U.S. Self-Care Marketing Awards Apr 22, 2025 Comments Comments Regarding Artificial Intelligence-Enabled Device Software Functions Apr 4, 2025 Press Releases and Statements CHPA Statement on Senate Confirmation of Dr. Makary as FDA Commissioner Mar 25, 2025