I recently wrote about major changes at the FDA’s Center for Devices and Radiological Health (CDRH), including the departure of long-time director Jeff Shuren and the search for his successor. I estimated that it would take a year to pick the next center director and for him or her to settle into the new job.
Reality moved much faster. On Tuesday, the FDA announced the selection of Michelle Tarver as the next CDRH director. This was no big surprise as FDA leaders have been signaling that Tarver would take the top spot. Still, her pick is a win for CDRH and its stakeholders. Tarver is a seasoned FDA professional who understands the regulatory process and the arcana of FDA administration.
This means a fast and efficient transition, and a successful one judging by the praise for Tarver. Importantly, given her experience and past roles, it’s possible to predict where Tarver will focus as she takes the CDRH helm.
Current CDRH initiatives will continue. As I last wrote, important CDRH initiatives – like digital device oversight and real-world evidence – will continue regardless of the leadership change. But Tarver’s selection means that CDRH also will support programs that are less well-established.
CDRH’s Total Product Life Cycle Advisory Program (TAP) is a good example. This pilot program, which promotes device innovation, is early-on and lacks the widespread support that other CDRH initiatives have. But don’t expect TAP to go away anytime soon. Tarver was at least in the room when TAP was formulated and her former boss – and TAP’s biggest advocate – is still at the FDA. That means that TAP will remain on CDRH’s priority list.
CDRH will focus on core regulatory responsibilities. Especially with the election drawing near, CDRH will focus on core duties like product review and postmarket oversight. Tarver is savvy, and focusing on bedrock roles keeps CDRH safely under the radar. This is a good place to be with so many unknowns about who will lead the government, including the FDA, and what their priorities will be.
Certainly, ongoing initiatives will continue. But don’t look for new initiatives or for the current ones to push beyond CDRH’s clear regulatory authority.
Conversations will change (kind of). No doubt, Tarver will prioritize patient engagement. Need proof? Look at her past roles, which include directing CDRH’s Patient Science and Engagement initiative and the Home as A Healthcare Hub program. Dr. Tarver is a strong patient advocate, and her commitment will permeate as she leads the device center.
This will mean some new priorities, like extending clinical studies to minority and at-risk populations. But prior CDRH initiatives are not going away. Instead, how stakeholders talk about these initiatives needs to change. Patient engagement and benefit, for example, become the up-front talking points. This is not a heavy lift because, at their core, efforts like digital innovation and real world evidence benefit patients. Smart stakeholders will promote such initiatives by highlighting the synergy between innovation and patient benefit.
Steve Silverman is the president of The Silverman Group, a consultancy that serves medical product companies on regulatory, strategy, and policy issues. Steve’s professional experience includes extensive time in senior FDA roles. At the FDA, Steve directed the CDRH Office of Compliance, where he led device-quality initiatives, engaged Congress and the press, and guided the office’s reorganization.
