Bradley Thompson, a Member of the Firm in the Health Care and Life Sciences practice in the firm’s Washington, D.C., office, was quoted in an article about radiological devices.
The article discussed how the 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). According to the article, the FDA hopes that doing so will produce more cohesive policies on diagnostic device review. However, the ODE says that the move responds to long-term discrepancies between how in vitro and in vivo diagnostics have been regulated by the FDA.
“The move is great for companies that make radiological devices,” said Thompson. “The management at OIVD is very strong, and the radiological group will find OIVD a happy home.”
Thompson continued by saying, “I think IVD companies will like the change, in that it gives OIVD leadership a slightly broader perspective by looking at all diagnostics. 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,” said Thompson. “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.”