Federal Register notice: FDA makes available a final guidance entitled Annual Status Report Information and Other Submissions for Postmarketing Requir...
Federal Register notice: FDA makes available two draft guidances on clinical and non-clinical study recommendations for medical devices seeking indica...
Federal Register notice: FDA makes available a final guidance entitled Fostering Medical Device Improvement: Food and Drug Administration Activities a...
Federal Register notice: FDA makes available a final guidance entitled Breakthrough Devices Program.
CDRH develops a Digital Health Frequently Asked Questions Web page to help developers bring innovative technologies to market.
FDA clears a Beacon Biosignals 510(k) for the Dreem 3S, a wearable headband with integrated machine learning algorithms to capture electroencephalogra...
FDA approves GlaxoSmithKlines NDA Ojjaara (momelotinib) for treating intermediate or high-risk myelofibrosis.
FDA publishes a guidance with its policy on participating in the medical device Voluntary Improvement Program.
