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 ...
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 ...
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 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 ...
While receiving more than 19,000 product submissions during 2023, CDRH granted marketing nods to 124 novel devices—covering premarket approvals and de novo clearances, but not counting COVID-era ...
CDRH has revised its procedures and criteria it intends to use in assessing whether a 510(k) submission meets an “acceptability level” for a substantive review. “Focusing FDA’s review resources on ...
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 ...
Despite pleas to Frank that he reject the agreement because it contained no restitution for victims who had problems with Guidant’s Prizm and Renewal implantable cardioverter-defibrillator devices, ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results