Jeff Shuren on FDA-Sponsor Engagement: Where It’s Been and Where It’s Going

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ARTICLE SUMMARY:

The FDA device center director joined the Market Pathways Podcast to talk about how opportunities for device firms to interact with FDA during the development and review of new devices have evolved, and his vision for the future: CDRH’s TAP proposal. “We have been building to this moment for now basically a decade,” Shuren tells us.

The number of ways a company developing a new device can engage FDA device reviewers and scientists has been growing over the past decade or so, and CDRH Director Jeff Shuren wants to double down on that trend. 

The last two iterations of the FDA device user-fee program have increasingly embraced the concept of interactive review, providing more opportunities for informal back-and-forth between reviewer and sponsor without stopping the review clock. In parallel, the Pre-Submission program expanded and the Breakthrough Device Program was established. Both of those frameworks, which provide opportunities for formal input or collaboration prior to a submission, are swelling in popularity faster than FDA’s budget to resource them.

CDRH has also launched programs to bring payors to the table with companies during early clinical trial design planning to support regulatory and reimbursement data needs in tandem. And the center has facilitated partnerships, including recent attention to so-called “collaborative communities,” to help solve sector-wide regulatory science problems in the pre-competitive space.

“I think we've arrived at the point where it's time to take the program to the next level and inject device innovation and safety in the US with a shot in the arm like it's never seen before.”

More recently, in response to the pandemic, the device center says it has had to relinquish conventional constraints on FDA-company communications to help expedite development of COVID-19 tests and supplies 

For Shuren, the time has now come to bring these efforts together into a bigger, more ambitious framework for early, multi-stakeholder engagement for companies developing new devices. “I think we've arrived at the point where it's time to take the program to the next level and inject device innovation and safety in the US with a shot in the arm like it's never seen before,” Shuren said in an interview on the Market Pathways Podcast.

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