Federal Register notice: FDA announces its Quality Management Maturity for Finished Dosage Forms Pilot Program for domestic drug product manufacturers...
CDRH posts a series of videos highlighting the progress the Center has made to date with implementing the current medical device user fee program.
FDA is announcing a requirement for electronic submissions to be submitted using a new Electronic Common Technical Document Module beginning 3/1/2022.
CDER announces two quality management system pilot projects to help inform an agency rating system.
Federal Register notice: FDA makes available a final guidance entitled Technical Considerations for Non-Clinical Assessment of Medical Devices contain...
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Biocompatibility of Certain Devices in Contact with Intact S...
University of Oxford researchers find that many comments on an FDA framework for modifying artificial intelligence and machine learning-based software...
FDA clears a See-Mode Technologies 510(k) for its Augmented Vascular Analysis, a medical artificial intelligence software for automated analysis and r...