On October 10, 2024, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) announced its agenda of proposed guidance documents to be published or developed in ...

Medical device lobbyists called for more staffing transparency in user fee negotiations with the Food and Drug Administration ...

Employees at the Food and Drug Administration’s medical device center on Tuesday received notice that they would be cut amid massive layoffs at federal health agencies. The reductions included people ...

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 ...

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 ...

CDRH says fewer than half of the postmarket studies required of the device industry as a condition of approval are completed in the proper time frame. Although industry is not accepting those findings ...

CDRH Unveils Medical Device Innovation Pathway Bombarded by demands that it be more supportive of medical product innovation (see, for example, the next story), FDA in February announced its Medical ...

For decades, FDA’s Center for Devices and Radiological Health (CDRH) has been recognizing standards that can be referenced in premarket medical device submissions. Congress broadly directed federal ...

With the evidence that sex and gender both significantly affect the course of many diseases and the function of medical devices rapidly mounting, the FDA’s Center for Devices and Radiological Health ...

Last week, the outgoing leader of the FDA’s devices center, longtime chief Jeff Shuren, M.D., endorsed acting head Michelle Tarver, M.D., Ph.D., on a stage in front of the medtech industry, saying she ...

Center for Devices and Radiological Health (CDRH), USFDA has the following research output in the current window (1 November 2024 - 31 October 2025) of the Nature Index. Click on Count to view a list ...