On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot communications program for improving the timeliness for communicating high-risk recalls.[1] The CDRH ...
On March 15, 2024, FDA published a white paper titled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together” (the AI White Paper) on the use of artificial ...
The sudden firing of Food and Drug Administration employees over the weekend is already affecting medical device submissions. The cuts could delay the time it takes to bring new products to market and ...
Many people who were fired from the Food and Drug Administration’s medical device center last week had their termination letters rescinded over the weekend, according to Advamed and three FDA ...
Retirements from the Food and Drug Administration are hardly shocking, especially in the wake of pandemic burnout. But when longtime medical device director Jeff Shuren announced his departure in July ...
In what the FDA described as a “transformative year” for its Center for Devices and Radiological Health, the agency set a new record in issuing green lights to innovative medical devices and ...
The FDA has officially posted its job opening for the director of its Center for Devices and Radiological Health—as it looks to replace Jeff Shuren, who is retiring after 15 years in the position. The ...
Peytant Solutions CEO John Schorgl explains how his device startup turned a complex FDA de novo application into a lasting ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback