Dive Brief:

• FDA continues to struggle in 2021 in balancing its coronavirus-related regulatory workload and non-COVID-19 activities, with the agency's performance in conducting 510(k) reviews suffering, according to Jeff Shuren, director of the Center for Devices and Radiological Health.   
• Review times for emergency use authorizations and pre-EUAs have increased which has "adversely impacted" reviews of non-COVID submissions including premarket approval applications, Shuren told the Food & Drug Law Institute annual conference Wednesday. Despite efforts to mitigate its coronavirus workload challenges, the CDRH chief said it's possible this year that FDA might miss some of the Medical Device User Fee Amendments performance goals to reduce the average total time to decision for PMA applications and 510(k) submissions.
• FDA won't review pre-submissions for in vitro diagnostic products until 2022 due to these constraints, Shuren said, unless they are for COVID-19-related, breakthrough designations or companion diagnostics. But "all of the [IVD] premarket submissions on hold will move forward, they'll have a lead reviewer, we will make progress" in 2021. Shuren acknowledged that the agency "might not meet" its MDUFA deadlines in those areas.  

Dive Insight:

Since early 2020, CDRH has been overwhelmed by a huge increase in regulatory work in response to the pandemic such as granting emergency use authorizations for COVID-19 tests, while the center has also continued to receive non-coronavirus submissions.

Despite last year's disruptions, Shuren had hoped that 2021 would be more of a "reset" with the agency getting a better handle on managing its workload and getting derailed pre-pandemic priorities back on course. So far, it hasn't worked out that way this year.

CDRH's resources continue to be stretched thin resulting in a slowdown in the center's review times.

"We have started to see adverse impact in some of our performance on 510(k)s," Shuren told FDLI on Wednesday. "Same story we're starting to see with PMAs."

The CDRH chief said that the center's staff "have literally been working around the clock," while warning that the work pace is unsustainable in the longer term with this "all hands on deck" approach and that concerns over the health, wellness and wellbeing of his colleagues keeps him up at night.

"I've never encountered in all my years in government anything like this," added Shuren, who compared the work environment at CDRH since the pandemic started to running a triple marathon. "I do worry about people leaving the center, burning out."

Nonetheless, Shuren said CDRH is "turning that ship around" and its overall performance with regard to reviews is "actually looking pretty good when it comes to premarket submissions" with the exception of the IVD delays.

On the digital health front, Shuren made the case that in spite of the COVID-19 pandemic FDA has made significant progress. He pointed to the agency's creation in September of the Digital Health Center of Excellence within CDRH to pilot policy and regulatory approaches tailored for these fast-growing technologies. "We know we need a different paradigm for these kinds of technologies," Shuren said.

It's been two years since FDA's April 2019 discussion paper on a regulatory framework to enable ongoing AI/machine learning algorithm changes to software as a medical device based on real-world learning and adaptation. However, Shuren noted FDA's action plan in January for establishing a regulatory approach to SaMD puts it on schedule for proposed guidance for an AI/ML framework in 2021, as well as "good machine learning practices" to evaluate and improve algorithms.

While the FDA's heavy coronavirus workload previously had a negative impact on the agency's efforts to issue policy documents, Shuren noted that those plans are "back on track" with guidance slated for 2021 including over-the-counter hearing aids and how to transition EUA-authorized products to full marketing authorization once the public health emergency ends.

Still, Shuren urged companies with EUAs for products seeking full marketing authorization as soon as possible.

"In the test world, we'll have some early De Novos and then move over to 510(k)," he added. "If you're looking to convert [EUAs], you've got a question, come talk to us."