The regulatory agency is looking for better ways to protect patients from injuries and deaths associated with surgical staplers.
Regulatory and Compliance
Here are a few ways to avoid triggering the on-sale bar and losing patent rights, post-Helsinn v. Teva.
The thermomechanical behavior and processing sensitivity of nitinol raise special considerations compared to conventional metals, FDA says in new draft guidance for medical devices containing the nickel-titanium alloy.
As artificial intelligence revolutionizes healthcare, the need for a tailored regulatory pathway for AI-based devices becomes crucial.
The company is bracing for a $25 million revenue hit after FDA ordered two of its mesh products off the market, but a bigger concern may be lying in wait.
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.
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.
Medical device innovators should pay attention to the recent court case for clues on how courts could view other hybrid inventions such as wearables and more.
Friday marks Scott Gottlieb's final day as FDA commissioner. Here is a review of the key regulatory milestones and controversies that occurred during his time as the agency's 23rd commissioner.
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.
An industry expert talks about the role communication and language play in clinical trials and regulatory compliance.
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.