Thursday, January 14, 2010

A re-org is underway at FDA and some details have just been released. According to the announcement, the radiology group from ODE is moving over to OIVD as of the 12th.  Donald St. Pierre is getting a new title: Acting Division Director for Radiology Devices, while Alberto Gutierrez continues to head up OIVD.

That's the public information at this point.  I wouldn't be surprised if this is the first step in a larger re-alignment of regulatory burdens.  Imaging technologies have gotten away with some impressively broad intended uses and many of our clients have, rightly, pointed out that the standards IVDs are held to don't seem to apply to technologies like MRI.

FDA is aware of this disparity and while they may be taking this step to "improve operational efficiency" I think that's not the end of it.  Moving imaging into OIVD is only going to make these disparities less tolerable.  Whether or not this move is intended to lead to harmonization of regulations, it seems like a safe bet that it's on the horizon.


EDIT: Post has been updated to reflect Donald St. Pierre's new title.

EDIT: Two weeks after we posted this, The Grey Sheet has more details.


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