Propelled by rising congressional and public concerns about cyber security, CDRH moved with unusual speed in August to finalize and release a new guidance document intended to assist industry and FDA ...

CDRH Moves to Strengthen Postmarket Surveillance It’s a cynical old joke that gets frequent play—in Washington: “I’m from the government and I’m here to help.” It got a re-run in September after CDRH ...

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 ...

As part of the US Food and Drug Administration’s continued commitment to protect and promote the health of all women, the Center for Devices and Radiological Health (CDRH) is sharing its Health of ...

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 ...

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 ...

After 15 years as head of the FDA’s Center for Devices and Radiological Health, Jeff Shuren, M.D., is retiring. It’s a decision that comes after 28 years in government, which has included representing ...

The FDA’s TEMPO pilot will evaluate a risk-based enforcement approach to assess how patient access to digital health devices ...