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 ...

Add Yahoo as a preferred source to see more of our stories on Google. Registered nurse Steve Van Dyke checks the blood pressure of Pauline Zocholl, 94, while on a home health care visit on March 23, ...

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 ...

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 ...

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 ...

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 ombudsman Les Weinstein resolved a whopping 81% of the complaints, disputes, and other contacts he received in 2006, including cases that were carried over from previous years, according to his ...

The draft agreement outlines the Food and Drug Administration’s goals for medical device reviews from 2028 to 2032.

Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) for almost 15 years, has announced that he will leave FDA later this year, ...

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 ...