Tag Archives: 510(k)

TCT 2013: What we didn’t hear

There’s a lot to be said for gatherings like TCT. It brings device makers, doctors, and FDA together in a way that seems formulaic, but there’s nothing like face time to help people with sharply opposing views to hash out…

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Being there first: Personalized medicine and the investor

I don’t directly invest in med-tech, but attending Transcatheter Cardiovascular Therapeutics for five years makes me wonder how an investor separates winners and losers. I know TCT 2011 has both, but which are which? Asking about the patient population is…

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A whole new world

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…

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Parallel review: Still not a big deal?

  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…

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The law of unintended consequences

  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. Remember FDA’s draft guidance on when to file a 510(k)? Among the things it stipulates…

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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…

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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…

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FDA to small firms: Thanks but no thanks

There’s nothing like having siblings who are several years older and in their teens. You admire them for being so mature and so big. When you wanted to hang out with them, though, maybe they told you to buzz off….

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Oh brother, it’s Big Brother

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…

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ReGen v. FDA: A test of government’s reach that’s sure to bloody noses

ReGen Biologics (Hackensack, New Jersey) has filed suit against FDA over the agency’s rescission of the firm’s Menaflex application, a slugfest that is certain to draw intense interest everywhere, from Capitol Hill to the boondocks of the medical device industry….

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