In today's edition of Medical Device Daily, I write that the proposal by the Institute of Medicine to trash the 510(k) mechanism in favor of a brand new scheme is impractical and will gain no traction. Not only does industry find this impossible to choke down, but even Jeff Shuren, MD, director of FDA's Center for Devices and Radiological Health, remarked that FDA believes “that the 510(k) process should not be eliminated,” although Shuren said he and his team are “open to additional proposals” for “continued improvement.” One caveat to the rejection of the IOM proposal is that even though...

Now that the Institute of Medicine (IOM) has fulfilled its task of making recommendations for the 510(k) program at FDA, all parties have had a chance to respond to at least the broad strokes of the IOM recommendations. The long-awaited report recommends that FDA dump the 510(k) program and start over. However, while the suggestion has plenty of critics in industry, even FDA indicates it has no intention whatsoever of making such a move. (Medical Device Daily)

If you enjoy participating vicariously in exercises in futility, take a gander at what's going on in Washington with regard to user fees for medical device reviews. Yesterday, Sen. Richard Burr (R-North Carolina) told FDA commish Margaret Hamburg, MD, than any user fee legislation that does not incorporate non-FDA days into the calculation of total 510(k) review days would face “a long and laborious process” to get the required legislation through the Senate Health, Education, Labor and Pensions Committee. Burr's position was essentially that FDA has not met the turn-around on applications called for in the previous user fee handshake,...

Ah, clichés. They're the stuff life is made of, eh? There's always the danger of resorting to them in my line of work. When I see them in my own copy, I feel a little like Harvey Korman's character in the Mel Brooks classic film “Blazing Saddles.” Korman's character is Hedley Lamarr (It's not Hedy, it's Hedley!!), the evil state attorney general who recoils at the use of the cliché “head them off at the pass.” “I HATE that cliché,” Lamarr said in disgust. Lamarr might have been a fictional...