The US Food and Drug Administration has ordered all manufacturers of “metal-on-metal” artificial hip devices to conduct post-market studies to see whether the implants are malfunctioning or causing health problems in patients.
The US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has issued
The US Food and Drug Administration (FDA) is considering whether to regulate electronic health records (EHRs) as medical devices as it develops new rules targeting software, according to Center for Devices and Radiological Health (CDRH) director Dr. Jeffrey Shuren.
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’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 .
In an effort to foster development of cutting-edge medical device technologies, the US FDA has proposed a new program,
On the heels of revealing some of its 510(k) reform plans on January 19, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) medical device regulatory unit has published a list of its four strategic priorities for 2011--including taking a more assertive role in promoting development of products the unit deems necessary to combat public health challenges.
A newly released FDA report has been made available for public comment until October 4, 2010.