Tag Archives: CDRH
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…
FDA’s resource dilemma: does more money equal more regulatory mischief?
September 23, 2011 – 7:21 AM
Much has been made of the slow-down in device approvals at FDA’s Center for Devices and Radiological Health, and the explanations range from a preoccupation with scientific and statistical minutia to a paranoia that yet another incident will subject the…
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.
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…
FDA report on NSE decisions: What does it not say?
June 17, 2011 – 11:57 AM
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…
FDA, devices and doom and gloom
May 25, 2011 – 9:38 AM
Is the sky falling? Device makers keep saying so By MARK McCARTY Medical Device Daily Washington Editor
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…
