Tag Archives: user fees

Mal-fee-sance; The FDA user fee controversy

If you like controversy, a job at FDA would be right up your alley, but it’s tempting to think some of these controversies are contrived. The question of the influence of user fees on FDA reviews has surfaced (yet again),…


A refreshing take on the state of the med-tech industry

Here at Medical Device Daily we’ve become accustomed to the doom-and-gloom stories about our industry. The medical device tax provision in the Affordable Care Act and other emerging realities of healthcare reform along with worldwide economic sluggishness, regulatory and reimbursement challenges, consolidation…


Chickens or lemmings? Washington and the FDA budget

There’s a lot of consternation and maybe even a little constipation of late about the U.S. federal budget, and rightly so. If the White House and Congress can’t come to some resolution about budget sequestration, the FDA budget could tighten…


Congress enjoys a rare moment of harmony with passage of FDA user fee act

With all the acrimony between Democrats and Republicans in Congress these days, it was truly edifying to see lawmakers on both sides of the aisle agreeing on a piece of legislation – and in the healthcare sector no less –…


FDA user fees: A necessary evil?

The FDA medical device review mechanism has come under fire from many quarters for some time now, but one of the criticisms of the 510(k) and PMA programs is that the reviews are funded by user fees, a claim that…


Device user fee discussions heading nowhere fast

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…