Tag Archives: IOM

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),…


Three really bad ideas

It has been said there are shortages in this world, but there has never been a shortage of bad ideas. In fact, the opposite seems to be true. Here are three really crummy ideas we should all hope end up…


IOM’s proposal to scrap the 510(k) is kaput: What’s next?

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

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…