The US Food and Drug Administration (FDA) has finalized its strategic plan for incorporating sex and gender differences into the development and regulation of medical devices. The Health of Women ...

The US Food and Drug Administration (FDA) saw a 243% spike in the annual number of foreign medical device inspections conducted by agency officials since 2007, according to a new report. “As medical ...

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 ...

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 ...

FDA issued a warning to drug-device combination manufacturers about nitrosamine impurities that could increase the risk 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 ...

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 ...

Speaking at the Incorporation of New Science into Regulatory Decisionmaking public meeting in February, recentlyappointed CDRH director Jeffrey Shuren said that the goal is to set clearer guidelines ...

In a letter to Dr. Michelle Tarver, newly appointed director of the Center for Devices and Radiological Health, a division of the Food and Drug Administration, seven members of Congress have asked the ...