The Biden Administration announces that it will end the current Covid-19 public health emergency declaration and national emergency declaration, which...
After more than 22 years at FDA, CBER Office of Tissues and Advanced Therapies director Wilson Bryan announces he is retiring in March.
FDA commissioner Robert Califf announces a new transformative vision for the agencys human foods program and the Office of Regulatory Affairs that add...
Federal Register notice: FDA announces the issuance of two Emergency Use Authorizations for diagnostic devices intended for use during the ongoing Mon...
Federal Register notice: FDA classifies software for optical camera-based measurements of pulse rate, heart rate, breathing rate, and/or respiratory r...
FDA classifies as Class 1 a Smiths Medical recall associated with a 12/2022 company-issued urgent medical device correction letter identifying two pot...
FDA posts a final guidance entitled Surveying, Leveling, and Alignment Laser Products that addresses radiation safety product performance standards.
FDA classifies as Class 1 a Medtronic recall of its Mahurkar 13.5Fr high-flow, dual lumen acute dialysis catheter based on a potential leaking conditi...