Shuren: CDRH reimagining medtech premarket review process

Editor’s note: The word “efficiencies” was changed to “deficiencies” in a quote from Jeff Shuren below.

WASHINGTON – The US Food and Drug Administration (FDA) is considering redesigning its device and diagnostics premarket review process to improve expectations, ensure better first-time submissions, and allow more flexibility in the review process, according to Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH). The objective would be to reduce the number of deficiency letters and complete more reviews in a single cycle.

Shuren made these remarks at Medical Device Manufacturers Association (MDMA) 2024 Annual Meeting on 18 April. While highlighting positive news, such as increased participation in the Total Product Life Cycle Advisory Program (TAP) and benefits of its Voluntary Improvement Program (VIP), he also noted the agency is looking to reform its premarket review program to streamline to process and ensure better predictability for sponsors.

“We're always looking for opportunities to do things better,” said Shuren. “We're engaged in a complete reimagination of our premarket review program currently.”

“Can we go towards eventually one cycle review in an agile manner of review where we can kind of sit down and go through it and not deal with interruptions,” he asked.

Shuren noted that the redesign would mean clear and reasonable expectations for both FDA and device sponsors. It would also mean incentivizing sponsors to file high-quality submissions that are well-organized and easy to navigate, which would lead to fewer major deficiencies. The redesign would create a more agile review and decision-making process for reviewers, minimizing submission idle time, streamlining the review and documentation process, and simplifying program-level and management concurrence.

Shuren said CDRH has gone back to the drawing board to create different models that address ongoing challenges and find ways to do things differently or that haven’t been done to improve the premarket review process. He said the agency will eventually implement those models in pilot programs to evaluate their outcome.

“We’ll probably start piloting a few things this year and then build out from there,” Shuren told Focus. “We wouldn’t do any kind of wholesale change.”

“We want to kick the tires a little bit, so it’s not going to disrupt anything that’s under review,” he added. “These are things we can roll out, learn a little bit, and then broaden it.”

While Shuren didn’t go into specifics about what areas of the review process the agency wants to change or test in pilot projects, he noted that a key focus is reducing the number of deficiency letters that are sent to industry.

During his talk, Shuren noted that CDRH has made significant progress under the Medical Device User Fee Amendments (MDUFA V) deal to help reduce deficiency letters by updating guidances, creating a deficiency liaison, holding monthly meetings with the deficiency liaison, and enhancing their example deficiency resources. By the end of the MDUFA V cycle, CDRH is required to send out a statement of basis for a least 95% of deficiency letters, and Shuren noted that so far the agency was able to do so for 75% of cases.

“But real success is that we don't have deficiencies in the first place,” said Shuren “Where we'd like to be is we have no or very few deficiencies, high-quality submissions, and we finished our review in one cycle. That really should be our shared objective at the end of the day.”

He also noted that having to issue deficiency letters was an inefficient use of the agency’s resources and affects staff morale.

Shuren: CDRH reimagining medtech premarket review process

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