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 ...

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 ...

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 ...

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 ...

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 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 ...

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 ...

For medical device companies, the harder truth is that almost nothing that slowed your last 510(k) had anything to do with ...