The US Food and Drug Administration (FDA) has published a 37-page draft guidance for industry on proper human factors testing and medical device design optimization.

The US Food and Drug Administration has announced changes to its recognized consensus standards used in

The US Food and Drug Administration will reduce medical device user fee rates for its 2012 fiscal year, due to $9.5 million in excess appropriations from 2011. The new rates have been published as US legislators and industry lobbying groups are aggressively questioning FDA arguments for fee increases when the Medical Device User Fee and Modernization Act comes up for renewal next year.

A highly anticipated report by the Institute of Medicine of the National Academies (IOM) has...

New 510(k) submissions. The new guidance, 510(k) Device Modifications: Deciding When to Submit a 510(k)...

A new analysis of 510(k) premarket review timeframes by the US Food and Drug Administration cites response times from companies to additional information requests as the key causes of review delays. Overall, the FDA study found that between 2001 and 2010, percentages of 510(k) submissions that prompted Additional Information (AI) requests increased steadily and substantially—from 38% in 2001 to 77% in 2010. Average 510(k) decision time frames during that same period followed a similar trajectory, particularly from 2005 onward: In 2001, 510(k) decisions took an average of 102 days to reach, and in 2010 that average increased to 140 days. (These numbers track closely to a recent analysis of 510(k) clearance timeframes conducted by Emergo.)

Highly anticipated draft guidance on mobile medical applications has been published by the FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER). Targeting specific subsets of mobile medical device applications , the guidance should help answer some longstanding industry questions of how—or whether—US and other regulators would approach such devices. The guidance could furthermore serve as a template for other medical device market regulators determining how to establish requirements for this burgeoning sector of the device industry.

The growing rate of US Food and Drug Administration inspections and warning letter issuances, already higher than last year, will continue to increase according to a report by FDANews.com (subscription required).

A new study by US medical device industry lobbying group Advanced Medical Technology Association (AdvaMed) finds that prices for medical devices and diagnostic products have increased at less than one-fourth the rate of other medical products and services due to high pricing competition.

New draft guidance from the US Food and Drug Administration would reclassify some in vitro...