FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Guide on Breakthrough Devices

[ Price : $8.95]

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

Digital Health Frequently Asked Questions

[ Price : $8.95]

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

Beacon Biosignals 510(k) for Sleep Monitor

[ Price : $8.95]

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

FDA OKs GSKs Blood Cancer Drug

[ Price : $8.95]

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

Voluntary Improvement Program Guidance

[ Price : $8.95]

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

Breakthrough Devices Updated Final Guidance

[ Price : $8.95]

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

De Novo Granted for Esophagus Cooling Device

[ Price : $8.95]

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

FDA Seeks Input on Drug Quality Management Maturity

[ Price : $8.95]

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

Forms FDA 3988 and 3989 Guidance

[ Price : $8.95]

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

AI is FDA Info Technology Plans Top Goal

[ Price : $8.95]

FDA says exploring how artificial intelligence can play a role in its regulatory operations is a top strategic goal of its just-re...