- Jeff Shuren, director of FDA's Center for Devices and Radiological Health, had hoped 2021 would be more of a "reset" with the agency getting a better handle on managing its COVID-19 workload and putting pre-pandemic priorities back on course. However, that reset did not materialize amid the ongoing public health emergency, Shuren told AdvaMed's annual conference Monday.
- "We would have had new priorities in '21 but we decided let's not make any changes, focus on COVID," Shuren said. While the FDA device chief said the agency expects to have "new priorities" in 2022, he was unable to provide details. "We're engaged in a process within the center hearing from our own folks ... Come the new year, we will have something to share."
- FDA's focus on COVID-19 has had a negative impact on the agency's non-coronavirus workload, including delays in premarket submissions and meetings as well as Medical Device User Fee Amendments performance goals. "Even as we get past COVID, there will be challenges for us to make good on some of the [MDUFA IV] goals" due to higher-than-expected workloads than when FDA negotiated the reauthorization, Shuren warned.
FDA, as part of its 2017 MDUFA IV commitments, agreed to tighter timelines to reach decisions for most medical device submissions in exchange for increased user fees and the introduction of a new user fee program for De Novo classification requests. In particular, the agency said it would reduce the average total time to decision for PMA applications and 510(k) submissions.
Now, Shuren says all bets are off despite CDRH's good faith effort to meet its MDUFA IV performance goals.
"We tried to make our best estimates [when MDUFA IV was negotiated] based on the best available data at the time. But MDUFA has no opportunity to mid-course correct," Shuren said, noting the number of pre-submission meeting requests CDRH has received "was significantly higher than we had projected, or at least we had resourced for."
Shuren also noted that FDA's breakthrough device program, meant to speed access to novel medical devices without compromising safety and effectiveness, is also under-resourced. He said the program is "taking off" but the agency "never had the resources to provide the kinds of interactions we had always hoped for" with manufacturers during the premarket review phase to provide them with FDA feedback in a timely fashion.
Despite lack of resources, the number of devices designated as breakthroughs has continued to grow. Shuren expects that in 2021 FDA is going to exceed the number of designations in 2020. "We wind up designating about 50% of the submissions we receive," he added. "Again, showing a very healthy pipeline but at the same time a big increase in the work that we need to do at the center."
While CDRH has provided "near real-time back and forth" engagement with medtechs on COVID-19 products that "dramatically cut development, evaluation and review times" during the pandemic, Shuren said that level of regulatory performance is "unsustainable."
Instead, CDRH in current MDUFA V negotiations with industry has proposed a Total Product Life Cycle Advisory Program, which would be voluntary and meant to speed earlier strategic talks between FDA and companies, including coordination with other interested parties like payers and professional groups.
Shuren said a TPLC Advisory Program (TAP) would ostensibly first be instituted as a pilot and leverage CDRH's COVID-19 regulatory experiences and the "power of engagement" fostered during the pandemic between the agency and manufacturers.
"Suppose we could make that fluid, dynamic and a back and forth in a proactive manner between the review team and the developer going forward. We know [TAP] can dramatically change things and that's what we have under consideration in MDUFA [V]," Shuren said.
However, medtech industry participants in MDUFA V discussions have questioned the need for TAP and expressed concerns about including private payers in such a process, according to minutes released from a virtual April meeting.
"Industry believes that some aspects of the TAP proposal, for instance related to convening stakeholders such as private payers, would extend beyond the scope of MDUFA and beyond FDA's purview overall and would require statutory changes to implement. Moreover, industry is concerned that it would drive up program costs and put the fundamentals of the device review program at risk," the April minutes state.
Janet Trunzo, AdvaMed's senior executive vice president for technology and regulatory affairs, has been part of the MDUFA V reauthorization meetings. Trunzo, who moderated Monday's CDRH town hall, said AdvaMed is "still engaged in the negotiations" with the FDA.
Shuren, who spoke virtually at the CDRH town hall with his arm in a sling, joked that some of the MDUFA V discussions with industry have been "rough and tumble" as evidenced by his injury. Responding to criticism during Q&A about the months-long delay in making minutes from the ongoing MDUFA meetings publicly available, Shuren said FDA will "certainly have additional meeting minutes out in the near future" though he wouldn't commit to a timeline.