bioMerieux recalls its Vitek 2 AST P631 after customer reports indicate an increase in the rate of non-detected methicillin-resistant Staphylococcus a...
Federal Register notice: FDA seeks comments on an information collection extension entitled Guidance for Industry on Formal Dispute Resolution; Appeal...
Federal Register notice: FDA announces a 9/20 Pediatric Advisory Committee to discuss pediatric-focused safety reviews.
FDA Review posts the Federal Register notices for the week ending 8/17/2019.
An FDA review of a post-approval study conducted by SynCardia Systems for its Temporary Total Artificial Heart Companion 2 Driver System finds elevate...
Federal Register notice: FDA extends the proposal period for its Quality Metrics Site Visit Program for Center for Drug Evaluation and Research and Ce...
Federal Register notice: FDA submits to OMB an information collection extension entitled Guidance for Industry: Controlled Correspondence Related to G...
Federal Register notice: FDA grants an alternative that permits manufacturer reporting of certain device malfunction medical device reports (MDRs) in ...