The FDA recently issued a Letter to Industry with recommendations for using Affirmation of Compliance (AofC) codes to expedite release of goods from US Customs and Border Protection (CBP) for imported medical devices. Use of the AofC codes is voluntary but recommended to avoid Customs delays. According to informal discussions with the FDA, proper use of AofC codes can reduce the Customs processing time from several days to a matter of minutes. We have listed some of the most commonly used AofC codes here .

The FDA's Center for Devices and Radiological Health (CDRH) has published a Letter to Industry dated 24 March 2011 outlining information importers should provide to ensure expedited entry of th

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

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

Business-friendly US lawmakers and the FDA’s 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 .

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

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

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

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