By Kirell Lakhman

According to the blog MyRAQA, FDA has initiated a re-organization in which the radiology group, typically an ODE denizen, will move to OIVD by Jan. 12.

In its Jan. 14 post, MyRAQA suggests it "wouldn't be surprised if this is the first step in a larger re-alignment of regulatory burdens." The blog said 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."

While FDA "is aware of this disparity" and believes it is taking the steps to "improve operational efficiency," MyRAQA believes "that's not the end of it."

"Moving imaging into OIVD is only going to make these [standards] disparities less tolerable," according to the post. "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."

As part of the re-org, Donald St. Pierre, former acting director of OIVD, will get a new title — acting division director for Radiology Devices. Alberto Gutierrez will continue to run OIVD.

Tilting at Windfalls

The post struck me as particularly noteworthy. Last summer, I wrote a short post about FDA's fiscal 2010 budget, in which it would be allotted $2.99 billion. Of that, CDRH, the arm responsible for in vitro and other molecular diagnostics, including some genome assays, would receive $349 million — a 13.7-percent improvement over fiscal 2009.

Perhaps the office could use some of this windfall to hire people who can explicitly seek to erase the "standards disparity" MyRAQA describes. Indeed, when the budget was unveiled OIVD had already received funding to hire 10 additional staffers whose principal aim will be to focus on personalized medicine issues — broad enough to encompass issue of standards disparities.

And just today CDRH's website says the agency plans to "Recruit, Develop, and Retain High-Quality Employees", in 2010, though it didn't say in what capacity the new staffers will work. But I suspect some or all of them will make their way to OIVD because that's where the fastest-growing component of its charge resides.

Also last summer I spoke with several people intimately familiar with FDA's budgetary- and regulatory-shaping machinery who told me they are cautious that OIVD’s budget, however bigger than the previous year's, may not help it fulfill its goals. Such a stumble, in turn, could stifle new development and clearance of new genomic assays, and make life difficult for CLIA labs performing existing genomics tests.

One of these sources, Jeff Gibbs, a director at the law firm Hyman, Phelps & McNamara, said “[i]f OIVD seeks to regulate a large segment of the molecular diagnostic laboratory-developed tests, or increase its regulation of direct access testing or otherwise expand its regulatory scope, then hiring 10 additional employees will probably be insufficient.”

Oh, IVD

This week comes a new twist. According to Sample sister publication Pharmacogenomics Reporter, Elizabeth Mansfield, OIVD's director of personalized medicine at the Office of In Vitro Diagnostics, said "things are changing hugely" at the agency.

Speaking at the Personalized Medicine World Conference here this week, she said CDRH will continue to take a "broader look at LDT regulations" based on the recommendations of the HHS Secretary's Advisory Committee for Genetics, Health, and Society, among other documents, according to PGx Reporter.

Mansfield added that the infamous IVDMIA draft guidance "is still on the table," a comment that could have used as a way to soothe test makers still jittery after Gutierrez last summer said the agency plans to start the final IVDMIA guidance from

Cryptically, Mansfield also she also said the 510(k) process "is likely to change at some point in the future, because it is felt it is not working properly now."