FDA's Center for Devices and Radiological Health published the results of its analysis of decisions on 510(k) applications between 2006 and 2010 (see the pdf of the report here), including some data from as far back as 2001, and several features jump out to the casual observer. The problem for CDRH managers is that the report suggest a number of stories – several of which the agency fails to tell – that will do nothing to dial down industry's pushback against FDA's more aggressive enforcement/compliance regime. The report is also certain to do nothing to drain the increased pressure on...

WASHINGTON – This year's edition of the annual meeting of the Medical Device Manufacturers Association (MDMA; Washington), included a talk by David Kappos, director of the U.S. Patent and Trademark Office, who discussed several topics, including the prospects for ending fee diversion at PTO in the shadow of the U.S. federal budget deficit. He emphasized the importance of passing patent reform legislation, and said suggestions that ending fee diversion would allow PTO to act as an unsupervised free agent indicate a need for a "fact-based" discussion of congressional and other oversight of PTO encoded in the House patent reform bill. (Medical Device Daily)

ReGen Biologics (Hackensack, New Jersey) has filed suit against FDA over the agency's rescission of the firm's Menaflex application, a slugfest that is certain to draw intense interest everywhere, from Capitol Hill to the boondocks of the medical device industry. This might be a lawsuit that wends its way quietly into history, but it could also rupture whatever cohesiveness there might be at the agency's Center for Devices and Radiological Health. At the very least, it will serve as a huge distraction for CDRH officials and impose yet more drag on operations...

The first day of this year's annual meeting of the Medical Device Manufacturers Association (MDMA; Washington) included the usual talks by FDA officials, but Jeff Shuren, MD, director of the agency's Center for Devices and Radiological Health, seemed to strike a more conciliatory tone than in recent public appearances. Shuren noted that several guidances are in the works for publication later this year, but he urged members of the audience to take their problems up a notch if they believe a reviewer's demands are irrational, promising "nobody is going to retaliate against you." (Medical Device Daily)