FDA has ordered Boston Scientific and Coloplast to stop selling surgical mesh intended for transvaginal repair of pelvic organ prolapse. Patient advocates say the action was not made soon enough and does not go far enough, but it is a step in the right direction.
Regulatory and Compliance - News
FDA-mandated studies indicate higher than expected levels of contamination on duodenoscopes after reprocessing.
FDA warns the public not to use devices or apps marketed to consumers that claim to help assess, diagnose, or manage head injuries.
France banned several types of textured breast implants Friday as a precautionary measure. The implants are suspected of causing a rare form of cancer.
In his final days at the helm of FDA, Commissioner Scott Gottlieb says the agency will consider a new regulatory framework for bringing medical devices to market that use advanced artificial intelligence algorithms.
FDA will continue to require a 510(k) clearance for in vitro diagnostic devices designed to detect the bacteria that causes anthrax.
Scott Gottlieb said on Twitter earlier this week that FDA was working to make all of the data regarding adverse event reports available to the public.
The federal agency’s recommendations call for physicians to give women more information about the cancer risks associated with dense breasts.
FDA is carefully monitoring the medical device supply chain amid a shutdown of facilities that use a gas called ethylene oxide to sterilize medical devices.
The Department of Homeland Security and FDA alerted people about cybersecurity vulnerabilities affecting Medtronic's implantable defibrillators. Medtronic is developing updates to further mitigate these vulnerabilities.
FDA said Johnson & Johnson's Mentor unit and Sientra have failed to comply with post-approval study requirements for their silicone gel-filled breast implants.
FDA is calling on the public, scientists, and industry to help enhance the agency's understanding of materials science and to advance the development of safer medical device materials.
Norman Sharpless, director of the National Cancer Institute, will become “acting” commissioner of FDA after commissioner Scott Gottlieb abruptly announced he is leaving the position.
The agency released a letter to healthcare providers pointing out the risks and said it would hold a public advisory committee meeting.