Tag Archives: CDRH

The problem in Washington: Is it really Capitol Hill?

The latest news about the Internal Revenue Service does nothing to comfort those who have to routinely interact with the agency, but it does seem to tie in with other behaviors by the Obama administration, regardless of whether anyone at…

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Three important med tech developments in January 2013

The new year is underway and a few things of interest to med tech firms have already cropped up. Here are three of the more interesting developments in the world of medical devices (and it’s only for the month of…

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Bull in a China shop: Jeff Shuren at CDRH

The Center for Devices and Radiological Health may historically be the most interesting of all FDA’s branches, but the goings-on at CDRH since 2009, the year Jeff Shuren took the helm, have been nothing short of eye-popping. When one looks…

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Election 2012: Is Jeff Shuren’s job on the line?

Jeff Shuren, MD, has brought a lot of changes to FDA’s Center for Devices and Radiological Health, but there are those who think Shuren has not gone far enough while others think he’s gone too far. None of this would…

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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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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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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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