Category Archives: CDRH

A City of Two Tales

Forgive me for ripping off Dickens, but a good headline is priceless. This posting, however, is about two tales of an agency (located near Washington) with which we are all familiar. For the first tale, FDA recently re-classified diagnostics for…

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The Hit and the Pendulum; FDA, politics and medical devices

Long-time observers of FDA’s regulation of therapeutic medical devices will note an oscillation over time, and we are now in a period in which the pendulum has reached as far as it can in one direction and is now headed…

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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 regulatory landmine: FDA and social media

Anyone who reads this blog on a regular basis knows I’m leery of big government, and I usually criticize government (most often FDA) for what it does rather than what it fails to do. It appears to be time to…

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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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FDA’s resource dilemma: does more money equal more regulatory mischief?

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…

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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 Remember FDA’s draft guidance on when to file a 510(k)?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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Top Five Things to Watch for in 2011

In the world of diagnostic and therapeutic devices, 2011 has already been a busy year, but a third of the year remains. There are still numerous developments that will trigger cheer and jeers, depending on where you sit. This is…

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Flashback: Three med-tech stories from August 2009

Those in the business of therapeutic or diagnostic devices know how quickly things can change, so let’s take a quick look at a few stories that appeared in Medical Device Daily in August 2009. After all, two years are less…

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Medtronic’s $2.5M InFuse fix: Off-label use + implant = headaches

The deal struck by Medtronic (Fridley, Minnesota) regarding an evaluation of adverse events associated with off-label use of the InFuse bone morphogenic protein is conspicuous, but not so much because it will cost the firm $2.5 million to have Yale…

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