|Trends & Perspectives|
The Gray Sheet reported that FDA Commissioner Margaret Hamburg signed the orders that officially moved the Radiological Devices Branch from the Office of Device Evaluation (ODE) to the Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD). FDA hopes that doing so will produce more cohesive policies on diagnostic device review. Issues under the jurisdiction of the radiological branch, which regulates diagnostic imaging equipment and other radiation-emitting devices, have been a source of high-profile tensions within ODE. However, the agency says the move responds to long-term discrepancies between how in vitro and in vivo diagnostics have been regulated by FDA.
Some industry analysts believe that FDA made the right decision, which should have a positive impact.
"The move is great for companies that make radiological devices," says Bradley M. Thompson, JD, an attorney at Epstein Becker Green (Washington, DC). "The management at OIVD is very strong, and the radiological group will find OIVD a happy home. There are some synergies from the agencyís standpoint in consolidating the various diagnostic modalities. While much of the science is different, and while the risks are different as well, the conceptual framework for regulating diagnostics has similarities between the laboratory and radiological devices. The radiological device branch will get more focused attention from the OIVD leadership as well. Furthermore, the companies that make radiological devices will find OIVD to be a good office to work with in that its smaller size makes the group, including specifically the leadership, more accessible."
Thompson added that from an IVD company perspective, the benefits are less clear. The move is potentially distracting for OIVD leadership that already has a lot on its plates, which might slow down certain policy initiatives as the leadership learns the radiological health issues. However, the distraction hopefully will not affect review times, unless management gets tied up with the clearance process for radiological devices.
"But I think IVD companies will like the change, in that it gives OIVD leadership a slightly broader perspective by looking at all diagnostics," says Thompson. "I find it helpful to think about other technologies when looking for creative solutions. Focusing too narrowly on the technology tends to cause people to become narrower when brainstorming. The IVD and radiological devices branches can learn from each other with regard to creative ways to review and clear new devices. They might find the infusion of new people and new ideas invigorating. It may also raise the profile of the office, making it easier for that office to get needed resources. The office has some very important work to be done with lab-developed tests and companion diagnostics, and it would be ideal if the office has a bit higher profile within CDRH and FDA."
Other analysts are skeptical about FDA's true motivations behind moving the radiological devices branch to OIVD.
"The move of the radiological devices branch to OIVD has very little to do with CDRH's attempt to better synchronize diagnostic policies between IVDs and diagnostic radiology devices," says Thomas M. Tsakeris, president, Devices and Diagnostics Consulting Group (Rockville, MD). "The concerns raised by the radiological devices branch were directed at upper-level ODE managers and management policy over the approvability of specific radiology devices which, over time, led to irreconcilable differences and mounting tension between review staff and managers."
Tsakeris added that placing the radiological devices branch within OIVD will not smooth out these differences but more likely further alienate radiology device review staff. OIVD was created in part because CDRH management believed that the science and risk profiles of IVD devices were uniquely different from other medical devices. Moreover, despite recent tension within ODE, radiology devices and reviewers have resided compatibly within ODE for decades.
"In short, the move of radiology devices to OIVD is a specious attempt to solve a larger problem within CDRH, that being the perception among many review staff that managementís decisions to approve or disapprove new medical devices is as much based on political science as it is on academic science, or regulatory science," says Tsakeris. "Regarding the move's effect on the future regulation of IVDs, I think it will be negligible. Although there is some overlap in so far as diagnostic statistics are concerned, IVDs and radiological devices are so different that the two review organizations will carry on by proceeding along the same separate paths they have followed in the past."
Other analysts are taking a wait-and-see approach to find out what the results will be from the move.
"The tensions reported between ODE and OIVD with regard to the two separate jurisdictions in diagnostics have been covered in the media," says Glen P. Freiberg, president, RCQ Consulting (San Diego). "The natural government reaction to such tensions has always been reorganization. While it may make sense to move the two areas under one roof, especially considering the similarity in objectives and software validation expertise needed, we cannot assess improvements from the change until we ask OIVD Director Alberto Gutierrez what is being done differently, who is doing something differently than before, and how. Putting competing tensions under one roof alone doesnít resolve those issues, but itís certainly easier to hide them."