Device Reviews Will Now Take Longer: Shuren
Recent staff cuts at CDRH will likely lead to “longer review times, at least in the near term,” former CDRH director Jeff Shuren said in a 4/3 Webinar on the current challenges facing the MedTech industry, clinical investigators, and regulators. The device user fee program is shaken up by the recent staff cuts, Shuren told the Webinar, which was hosted by regulatory consultants firm NAMSA (see video replay here), and many more staff will likely leave on their own over the next several months due to poor morale and the inconvenience of being forced to return to the office last month.
One of the challenges moving forward with the device Center’s user fee program is ensuring it has the necessary expertise, and so it is important that the agency is focused on recruitment and retention, according to Shuren. “When I first came to the Center, we had a high attrition rate, and there were people who had concerns about the environment,” he said. “Industry had concerns that if the lead reviewer changes, and they were seeing that happening in the middle of the review, it can be very disruptive. And we spent a lot of time trying to enhance that environment, building kind of a program to better recruit, retain top talent, and getting people seasoned further in their career, and coming in the door with a variety of backgrounds, and we got attrition down to 6%... You know, unfortunately, a lot of the people involved in those efforts have also been part of the RIFs [reduction in force].”
In the long term and with the Trump Administration’s mantra of doing more with less through efficiencies, Shuren supported using artificial intelligence (AI) tools to help in the pre-market reviews. He said there are lots of opportunities there, and “in fact, the Center was already looking at those and starting to invest in tools to kind of leverage that to make it a more effective, efficient program… It’ll be important to continue efforts on data management because you have to make sure the data that’s already there to be leveraged, and that coming in the door, is cleaned up, and it’s consistent. You have a taxonomy, and there’s tagging so you can make the best use of that data. And we had an effort underway to do that... So hopefully that gets expedited.” He noted that some of the staff involved in that were part of the RIFs.
Additionally, Shuren said there’s been discussions on greater use of navigator tools for developers that have been under development at CDRH’s Digital Health Center of Excellence that would provide advice on policies and how they impact a device relevant to its technology. “So rather than having to ask the expert, companies can get an answer through that tool,” he said, adding that the Center has been looking at how to use generative AI for some of those tasks.
With all the changes likely occurring at the Center, Shuren said he hoped it “doesn’t compromise the rigor of the evaluation that’s performed. Having robust science to inform decision-making has really been the lifeblood of the agency. Patients and providers rely on the FDA to assure those devices are safe and effective, and industry relies on them too for that seal of approval to have consumer confidence. Over time, we’ve become a gold standard in medical devices. We weren’t always there, but we’re there today, and hopefully that isn’t compromised…”