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Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Biocompatibility of Certain Devices in Contact with Intact S...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...
An anonymous source tells CNN that AstraZeneca took several weeks to deliver data to FDA on the Covid vaccine trial participant illness that led to a ...
Consumer Reports says FDA has been inappropriately redacting product names from some dietary supplement adverse event reports covering hospitalization...
The Justice Department says Merit Medical Systems will pay $18 million to resolve a whistleblower complaint that it paid advertising kickbacks to heal...