Federal Register notice: FDA posts a list of ninee information collections that have been approved by OMB.
FDA classifies as Class 1 an Allergan July recall of its Biocell textured breast implant products.
FDA publishes four guidances giving its thinking on several aspects of the 510(k) submission process.
FDA clears the GE Healthcare Critical Care Suite that uses artificial intelligence algorithms embedded on a mobile X-ray device.
Federal Register notice: FDA announces a 10/7 Science Board meeting to hear CBERs response on its research program.
Federal Register notice: FDA announces an 11/4 public hearing to obtain input on the use of fecal microbiota for transplantation to treat Clostridium ...
Researchers say they could not find a clear threshold of magnitude of treatment effect that would lead FDA to not request randomized clinical trials i...
Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Edwards Lifesciences Pericardial Aortic Biopros...