FDA hopes that shuttling its Radiological Devices Branch to the Office of In Vitro Diagnostic Device Evaluation and Safety will produce more cohesive policies on diagnostic device review.

Issues under the jurisdiction of the radiological branch, which regulates diagnostic imaging equipment as well as other radiation-emitting devices, have been a source of high-profile tensions within the Office of Device Evaluation, but the agency says the move responds to long-term discrepancies between how in vitro and in vivo diagnostics have been regulated by FDA.

FDA Commissioner Margaret Hamburg signed the orders in January that officially moved the review branch from its current home in ODE to a new spot in OIVD (¹ 'The Gray Sheet' Jan. 25, 2010).

"We found that we were drifting somewhat in how OIVD was regulating diagnostics and how some of the ODE was doing some of their diagnostics," explained OIVD Director Alberto Gutierrez.

OIVD will now house four product divisions - the division of chemistry and toxicology devices; immunology and hematology devices; microbiology devices; and, now, radiological devices.

The center originally tried to deal with the disparities by maintaining a core group of statisticians that worked with both offices, he said.

"They kind of acted as a go-between," he explained, but "that just didn't seem to be doing the job as well as we would like."

"We came to the realization that this would probably be a better fit," Gutierrez said.

Will Move Reduce Tensions, Review Delays?

Stakeholders outside the agency say these policy clashes were manifest in disputes between branch reviewers and the upper management of ODE.

"These tensions have made it difficult for ODE leadership to effectively manage the radiological devices branch, particularly where there have been disagreements between reviewers in the branch," said attorney and radiologist John Smith, a partner in the law firm Hogan & Hartson who represents device firms before FDA, in an interview.

The public got wind of internal conflicts through letters by anonymous CDRH staffers accusing senior management of intimidating reviewers to modify scientific evaluations (² Also see "FDA Whistleblower Letter Released At Sebelius Confirmation Hearing" - Medtech Insight, 6 April, 2009.).

One of the few device-specific examples ³ cited in the letters, sent to members of Congress, FDA leadership and President Obama, disclosed a decade of disagreement between radiological branch reviewers and ODE management over the approval of computer-aided detection devices for imaging analysis.

The agency does not dispute there are disagreements, but stresses that the office move results from broader regulatory concerns, rather than personal strife.

"Just because you have disagreements doesn't mean you necessarily change around your structure," said Peper Long, an FDA spokeswoman. "But in this case, the OIVD structure was a natural fit for the diagnostic nature of radiology devices."

Gutierrez continued: "Diagnostics are a different species altogether. I think ODE management has been feeling for a while that perhaps having the same policies for all diagnostics is a good idea.

"Sometimes when you have that kind of [situation], you do have disagreements and people see things differently."

Hogan & Hartson's Smith said the move will likely calm some fears among device makers.

"It will allow the apparent tensions between the Radiological Devices Branch and ODE management to be addressed so that these issues don't turn into the focus of product review," Smith, also a member of the Radiological Society of North America, said.

"Every application is unique, but if the reviewing branch and management are not in agreement as to how to proceed on specific applications or even broader technologies, those types of disagreements can slow down the agency's reviews," he explained. "Such delays can certainly impact sponsors who are seeking to move those submissions or types of technologies forward."

Search Is On For Permanent Division Heads

Rather than reporting to ODE managers such as Janine Morris, acting director of the Division of Reproductive, Abdominal and Radiological Devices, and ODE Director Donna Bea Tillman, the group will now work under OIVD's Gutierrez and deputy directors Don St. Pierre and James Woods.

Otherwise, the radiology devices group will retain its current staffing, and stay put physically, for now, Gutierrez said.

Acting branch chief Michael O'Hara will be acting associate director for the division. St. Pierre is acting radiological devices division director.

Gutierrez says OIVD will have to make some organizational changes to "make everything flow seamlessly in the office," but the goal is not to change the structure dramatically.

The office will conduct a public search for a permanent division chief and associate director in the near future, he said.

He said he hopes there will be substantive interaction between radiology devices and the rest of the diagnostics office.

"We are one organization," he emphasized.

OIVD: Taking Out The "IV", and Even "D"?

One concern regarding the move is that many radiological products, such as radiofrequency ablation devices and cancer radiation treatments, are not diagnostic in nature.

But since the entire branch is transferring to OIVD, "all the resident expertise is there," Hogan & Hartson's Smith said.

He added that the group can still draw on other ODE divisions and branches for additional expertise, as needed. "There's always the ability to have a collaborative review with other offices."

On a broader scale, OIVD's Gutierrez said device center director Jeffrey Shuren and the CDRH office heads are determining the best fit for various device products going forward.

The non-diagnostic radiology devices "may stay with us," Gutierrez noted. "I don't know what would come out of that process." FDA may decide there are stronger reasons for keeping products like ablation catheters and brachytherapy cancer therapies at OIVD rather than for moving them elsewhere, he explained.

When all is said and done, the diagnostics chief said it is "very likely" that OIVD will change its name to better reflect its broader jurisdiction. "We would like to integrate the group and not have them feel like they are an appendage to OIVD."

Smith said he was "cautiously optimistic" that the move would benefit radiological device makers. "There are of course a lot of unknowns when you move one of the largest branches in the Office of Device Evaluation into an entirely new management structure," he concluded.

Office Issues Include Radiation Overdose And LDTs

The diagnostics office has a few other high-priority items on its plate in addition to integrating radiological devices, including some new regulatory issues that the branch brings to the table.

For example, OIVD will be taking "a serious look" at recently identified radiation overdose issues, Gutierrez said. Last December, FDA announced it was investigating hundreds of cases of radiation overexposure from computed tomography imaging scans (⁴ Also see "FDA Investigates CT Radiation Overdose In Multiple States, Facilities" - Medtech Insight, 14 December, 2009.).

In addition, the office will continue to devote resources to issues surrounding personalized medicine and the co-development of companion drug and diagnostic devices, Gutierrez said.

OIVD is also still working through questions on potential oversight over lab-developed tests, which FDA is not actively regulating right now (⁵ Also see "Would Expanded Lab-Test Regulation Overstep FDA’s Legal Limits?" - Medtech Insight, 16 March, 2009.).

- Jessica Bylander ( ⁶ j.bylander@elsevier.com )

Radiology Devices Move To OIVD: More Cohesive Dx Reviews Ahead?

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