Tag Archives: IOM
IOM’s proposal to scrap the 510(k) is kaput: What’s next?
August 1, 2011 – 7:31 AM
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…
Controversial 510(k) changes still up in the air
March 1, 2011 – 1:00 PM
In January when the FDA unveiled its 25-point plan to change the 510(k) clearance program, currently the quickest and most commonly used pathway to getting a medical device to market in the U.S., it appeared that a smooth landing might…
