Two medical device associations suggest ways to improve an FDA draft guidance on the Voluntary Malfunction Summary Reporting program created under MDU...
CDER describes a research study using flow microscopy and convolutional neural networks to monitor changes in product quality attributes.
FDA clears a DiA Imaging Analysis 510(k) for its LVivo IQS, a new artificial intelligence-based vendor-neutral software intended to help users in acqu...
Universal Meditech recalls (Class 1) its Skippack Medical Lab Covid-19 Direct Antigen Rapid Tests (Colloidal Gold) because they did not have FDA autho...
FDA commissioner Robert Califf easily manages criticisms of the agencys handling of the Covid-19 pandemic during a 2/8 House Energy and Commerce joint...
FDA warns the Palm Beach Fertility Center about significant repeat deviations from cellular and tissue regulations.
An FDA Office of Criminal Investigations probe leads to a Puerto Rico federal grand jury indictment against Magnetic Healer and three individuals char...
Federal Register notice: FDA announces the renewal of its Cellular, Tissue, and Gene Therapies Advisory Committee for an additional two years beyond i...
