COLUMBUS, OHIO: Worries about the impact of US Food and Drug Administration (FDA) review timelines and the growing use of artificial intelligence in regulatory processes are fueling conversations between the agency and MedTech stakeholders about whether current systems consistently support effective review, communication, and accountability.
During an April 22 session discussion at MedCon 2026, concerns were addressed regarding how performance goals established under the Medical Device User Fee Amendments (MDUFA) may influence FDA review practices and contribute to operational strain at the agency.
Barb Marsden, Acting Director in the Office of Regulatory Programs (ORP) within the FDA device center’s Office of Product Evaluation and Quality (OPEQ), said the agency is aware of these pressures and has been examining them internally as workload demands increase.
“These are things that we talk about often at our manager meetings with our staff,” Marsden said. Indeed, “we are seeing signs of strain. …These are things that happen when we are pushed to our limit. We’re running out of bandwidth to get all our work done.”
Marsden pointed to staffing challenges and resource constraints as factors affecting review capacity, including delays in certain submission types. She noted that reductions in experienced personnel have added to the burden on remaining staff.
“We’re learning how to use AI in the most appropriate ways possible. We’re still figuring that out.” – Barb Marsden
“We’ve lost staff that used to manage those programs … and reviewers in general are just limited in bandwidth,” she said.
Marsden further said the agency is working to improve transparency and tracking around reviewer interactions with sponsors, particularly as part of current MDUFA VI negotiations.
“We are going to start tracking interactions,” she said, encouraging sponsors facing specific issues to contact her directly to help resolve concerns. “When you send in an interactive review question, we’re going to track that response.”
During the MedCon session, MDMA President Mark Leahey said manufacturers continue to see inconsistent application of deadlines across FDA review teams. While some reviewers allow flexibility when appropriate, others adhere strictly to timelines, even in cases where a short extension could support a successful outcome. But he noted that even a brief extension of a few days can involve tradeoffs due to the agency’s performance goals.
“I think everyone would agree that if you have these outliers where an extra five days would get you across the finish line, that’s the best use of everyone’s time,” Leahey said. “Compelling a withdrawal and then resubmitting … extends the timeline well beyond what’s in anyone’s best interest.”
Both Leahey and Marsden indicated that ongoing discussions around reporting, training, and process updates may help address these concerns while maintaining overall review goals.
Questions Raised Over AI Use in FDA Review Process
Concerns about how AI tools such as FDA’s Elsa are used in review processes also emerged during the MedCon discussion, particularly around transparency and potential impacts on submissions.
The FDA’s Marsden said the agency is still adapting to the use of AI across the regulatory ecosystem, but emphasized that responsibility for review decisions remains firmly with human reviewers.
“We’re learning how to use AI in the most appropriate ways possible,” Marsden said. “We’re still figuring that out, but I can assure you that reviewers, no matter how they use AI, are still responsible for reviewing the application, and they are responsible for signing their name at the end of their review.”
Marsden stressed that reviewers are accountable for the accuracy of their assessments and any deficiencies identified in their review documents.
“When they sign their name to something, they take that very seriously,” she said. “They are making sure and verifying that what they have identified in their review … is accurate and validated.”
She also pointed to existing mechanisms for addressing concerns if stakeholders believe a review issue is off base. “You can flag any deficiency that you think is inappropriate or unfair,” Marsden said. “I would encourage you to use that process.”
