FDA Related News

Federal Register

Final Guide on Device Improvement Program

Federal Register notice: FDA makes available a final guidance entitled Fostering Medical Device Improvement: Food and Drug Administration Activities a...

Federal Register

Guide on Breakthrough Devices

Federal Register notice: FDA makes available a final guidance entitled Breakthrough Devices Program.

Medical Devices

Digital Health Frequently Asked Questions

CDRH develops a Digital Health Frequently Asked Questions Web page to help developers bring innovative technologies to market.

Medical Devices

Beacon Biosignals 510(k) for Sleep Monitor

FDA clears a Beacon Biosignals 510(k) for the Dreem 3S, a wearable headband with integrated machine learning algorithms to capture electroencephalogra...

Human Drugs

FDA OKs GSKs Blood Cancer Drug

FDA approves GlaxoSmithKlines NDA Ojjaara (momelotinib) for treating intermediate or high-risk myelofibrosis.

Medical Devices

Voluntary Improvement Program Guidance

FDA publishes a guidance with its policy on participating in the medical device Voluntary Improvement Program.

Medical Devices

Breakthrough Devices Updated Final Guidance

FDA publishes an updated final guidance on the Breakthrough Device program.

Medical Devices

De Novo Granted for Esophagus Cooling Device

FDA grants Attune Medical a de novo marketing authorization for its ensoETM device and its use to reduce the likelihood of ablation-related esophageal...

Federal Register

FDA Seeks Input on Drug Quality Management Maturity

Federal Register notice: FDA establishes a docket to solicit stakeholder comments to assist the agency in developing a Quality Management Maturity pro...

Forms FDA 3988 and 3989 Guidance

FDA publishes a guidance on using forms FDA 3988 and 3989.