FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Livmor Wearable Halo AF Detection System Cleared

[ Price : $8.95]

FDA clears a Livmor 510(k) for the Livmor Halo AF Detection System, a physician-prescribed wearable device that provides continuou...

Avoid NSAIDs in Pregnancy After 20 Weeks: FDA

[ Price : $8.95]

FDA cautions against pregnant women using prescription or OTC NSAIDs after 20 weeks because they can lead to low amniotic fluid.

Guide on IVD Biotin Interference Testing

[ Price : $8.95]

FDA posts a final guidance entitled Testing for Biotin Interference in In Vitro Diagnostic Devices.

Former FDA Spokeswoman Lands as Chief of Staff Advisor

[ Price : $8.95]

Despite being removed from her post, controversial former FDA chief spokeswoman Emily Miller remains at the agency as senior advis...

CDER Starting 2 Quality Management System Pilots

[ Price : $8.95]

CDER announces two quality management system pilot projects to help inform an agency rating system.

Device Advisory Panels Seek Voting Members

[ Price : $8.95]

Federal Register notice: FDA seeks nominations for voting members to serve on its Device Good Manufacturing Practice Advisory Comm...

Draft Guide on Biocompatibility of Devices Contacting Skin

[ Price : $8.95]

CDRH posts a draft guidance entitled Select Updates for Biocompatibility of Certain Devices in Contact with Intact Skin.

Labeling Carve-Out Court Decision Explained

[ Price : $8.95]

Attorney Sara Koblitz says a Federal Circuit Court of Appeals decision casts doubt on the long-established practice of generic dru...

Technical Considerations for Devices with Nitinol

[ Price : $8.95]

FDA issues a guidance on technical considerations for non-clinical assessment of medical devices containing nitinol.

Technical Suggestions on FDA Myeloid Leukemia Guidance

[ Price : $8.95]

Six drug companies submit technical comments on an FDA draft guidance on drug development for acute myeloid leukemia.