CDRH director Dr. Jeff Shuren [Image courtesy of FDA]
Medical device industry insiders will have to wait until the new year to get a better idea of the post-pandemic priorities at the FDA’s CDRH.
That was one of the big takeaways from Dr. Jeff Shuren’s remarks at the virtual CDRH Town Hall held yesterday at AdvaMed’s The MedTech Conference, which takes place this week as a combination of virtual presentations and live presentations events in Washington, D.C. and Minneapolis.
Shuren, the director of FDA’s Center for Devices and Radiological Health, said the center is “starting to turn the corner” on catching up on submissions. Additional dollars from Congress, he said, allowed CDRH to bring on more people, leverage contractors and make changes in policy and process.
FDA is even coming out of the COVID-19 pandemic with dedicated resources to establish a supply chain and shortage prevention program.
At the same time, the center’s focus on combatting the novel coronavirus has produced some achievements, including nearly 1,700 medical device authorizations.
“Because of COVID, we decided to stay the course,” Shuren said. “We would have had new priorities in 21. But we decided, ‘Let’s not make any changes. Focus on COVID. Focus on the day job. In 2022, you can expect new priorities that build on what we’ve already achieved. Our priorities also tend to focus on things that are cross-cutting — the actions we can take to drive progress and transformation in a variety of areas to ultimately achieve our vision.”
Shuren envisioned CRDH leveraging the flexibility its staff learned from the pandemic to create a Total Product Life Cycle Advisory Program — a proposal the center has brought up in current MDUFA V negotiations with medtech. “It would be voluntary, something that would be done as a pilot, but it leverages our experiences out of COVID and that power of engagement.”