The US FDA’s Center for Devices and Radiological Health (CDRH) has issued recommendations to improve

Effective March 8, the US FDA has issued modifications to the list of standards used...

At a US Food and Drug Administration town hall meeting held March 10 in Irving, TX, Center for Devices and Radiological Health director Dr.

The US Food and Drug Administration (FDA) has issued a clarification regarding medical device manufacturers’ and importers’ compliance with

The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) would see an appropriation of $329 million—a 4.8% increase over current levels—in the Obama administration’s proposed 2012 budget. Total CDRH funding would total $395 million, with $66 million from industry user fees, if the administration has its druthers, according to The Gray Sheet .

Business-friendly US lawmakers and the FDA’s Center for Devices and Radiological Health director Dr.

Opponents of the Food and Drug Administration’s reform efforts targeting medical device reviews have a sympathetic ear in Joe Pitts, the Republican congressman from Pennsylvania who now chairs the Hou

A new study examining high-risk recall rates of medical devices in the US as added weight to contentions that the Food and Drug Administration’s

In an effort to foster development of cutting-edge medical device technologies, the US FDA has proposed a new program,

Jaw implant manufacturers are apparently the latest segment of the medical device industry to experience the new get-tough stance by US regulators. The three major manufacturers of temporomandibula