Tag Archives: 510(k)
A whole new world
October 28, 2011 – 9:44 AM
Five years ago this month my byline began appearing on the pages of Medical Device Daily. When I first joined the MDD staff in October 2006 I knew very little about this industry. It was like moving to a new…
Parallel review: Still not a big deal?
October 11, 2011 – 7:14 AM
Well, FDA and the Centers for Medicare & Medicaid Services are at it again with parallel review, but this time they’ve tacitly acknowledged what everyone knew all along; that it would never be willingly adopted by more than a…
The law of unintended consequences
September 7, 2011 – 6:22 PM
The title of this posting pretty much says it all, but I’m paid to tap out words on my keyboard. So here we go.
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…
Device user fee discussions heading nowhere fast
July 28, 2011 – 11:51 PM
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.
Oh brother, it’s Big Brother
July 8, 2011 – 8:35 AM
There is an Irish aphorism which states: “Anything that keeps a politician humble is healthy for democracy.” The same might be said of bureaucrats. What sometimes strikes me as odd is that you can easily find coverage of the miscues…
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…
