Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “FDA: Device Center’s Total-Life-Cycle Reorganization to Begin March 18,” by David Roza. (Read the full version – subscription required.)
Following is an excerpt:
FDA’s device center announced on Wednesday (March 13) that it will launch its long-planned Internal reorganization aimed at addressing the total life cycle of products on March 18 and, should all go as planned, complete the overhaul by Sept. 30, 2019. Though the announcement did not reveal any new details on how that transition will unfold, it marks an official start to an initiative the agency has heralded since it was first announced in early 2018.
The goal of the reorganization, FDA said, is to create a faster, better integrated organization for dealing with product issues throughout a device’s total product lifecycle. Instead of the current system, which runs separate offices for each stage of a product lifecycle, the reorganization will “integrate [the device center’s] premarket and postmarket program functions along product lines, allowing our experts to leverage their knowledge to optimize decision-making across the product life cycle,” FDA said.
However, one device industry expert said he is skeptical the reorganization will result in any substantial changes. Brad Thompson, a member of the firm Epstein Becker Green, told Inside Health Policy the changes “feel more like form than substance.” …
FDA has been piloting a TPLC approach since June, the device center said. Implementation will take place in a phased approach, and timelines will vary by office, the center added.
“Full implementation of the new structure will increase information-sharing across the Center, enhance collective decision-making, and improve work-life balance and increase professional opportunities for employees,” the center said.
However, Thompson said he would need to see more details about how the new OPEQ would be organized for him to determine whether it would make an impact. As of now, he said, he suspects the Offices of Compliance, Device Evaluation, Surveillance and Biometrics will “simply become subsidiary offices [of the super office] … It’s hard for me to imagine that having much impact.”
Thompson said he was also unsure how the changes would affect any particular FDA employee’s day-to-day job.
“Maybe as we learn more we will see that it actually produces a change, but for the most part it seems to be primarily just consolidating the reporting structure at a level below the office of the center director,” he said. “It is just not obvious to me what tangible change that will bring.”