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 ...

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 ...

On November 21, 2024, FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot program aimed at improving public notice about potentially high‑risk medical device recalls. The pilot ...

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 ...

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 ...

The U.S. Food and Drug Administration (FDA) may soon require manufacturers of medical devices and supplies to apply unique device identification (UDI) mechanisms to individual items so they can be ...

The newest controversy concerned a rule making from which commissioner Margaret Hamburg had to recuse herself due to a perception of possible conflict of interest—ironic, considering that she is the ...