Device User Fee Activities Hurt by Covid Demands: Shuren

CDRH’s user fee commitments are being negatively impacted by the Center’s top-priority Covid-19 work, director Jeff Shuren told a 12/3 Alliance for a Stronger FDA Webinar.  Since the beginning of the Covid-19 emergency, the Center has accepted over 5,000 feedback requests related to Covid-19 products alone. “At the same time, the amount of work that we get for non-Covid-related devices hasn't changed and we’re getting the same number of submissions,” Shuren said, adding that among these has been an increase in submissions for innovative technologies.

All the extra Covid-19 submissions and related engagements with industry developers are having a ripple effect to the detriment of review times for PMAs and 510(k)s, he told the Alliance. He said the added work is putting at risk the Center’s ability to meet its commitments under the user fee program and a number of the other things that it’s engaged in are starting to slow down and going on the back burner.

“Because Covid-19 is the top priority, we are anticipating that those challenges are only going to get worse,” Shuren said. “Already we've had to delay holding meetings with a number of companies on the non-Covid-related products coming through. Some of the submissions now are taking longer, and then what’s going to happen when many of the developers for Covid-19 products are going to come back in the door with submissions for full marketing authorizations? And we anticipate starting to see that wave as we move into 2021.”

Covid-19 is also guiding FDA to be more flexible through its emergency use authorizations that permit CDRH to be able to make changes very quickly, tailored to the circumstances and technology. Shuren also sees flexibility benefiting the Center’s ability to put out guidance documents rapidly and being able to make important modifications or risk modifications to those documents. During the pandemic, he said over 25 guidances pertaining to medical devices have been posted to make it easier to get important products out to patients and providers. “And it's those kinds of flexibilities that are things that we think are important not just to continue in the pandemic, but also to do this in peacetime,” he said.

“In fact,” Shuren continued, “regulatory flexibility will become increasingly important as we are dealing with many of the emerging technologies today because we’re seeing the kinds of technologies that are not well suited for regulatory paradigms that were essentially created four decades ago, and particularly around software-based technologies. That's not the products Congress had in mind when they set up the frameworks. And so having that flexibility is going to be important that we meet patient’s needs of assuring devices are safe, while also that they are providing value to patients and patients and getting timely access to them.”

Looking ahead to 2021, Shuren said the Center plans to launch a Safer Technologies Program (STEP). This is an off-shoot of the Center’s breakthrough devices program that addresses devices focused on technologies for treating or diagnosing life threatening, or irreversibly debilitating conditions. STEP, he said, will be for those technologies treating or diagnosing all the other conditions, but they are expected to be safer than alternatives in the market. In these situations, CDRH would offer the same additional services as with breakthrough devices, including a lot more engagement and a lot more fluid interactions, but no changes in the standard to market.

Another big priority is digital transformation, Shuren told the Alliance, with a customer collaboration portal launching next year that will feature a “FedEx-type” tracker for companies to track their submission while under review. Also, recently the Center has introducing electronic templates for the review staff. “It walks them through in a much more logical fashion the key questions they need to answer in the review, and makes available intuitive decision aid tools as well as important guidances for that kind of review,” he said.  

The templates were piloted for 510(k)s last year, and they’ve now been released for anyone to use. They are available on CDRH’s Web site under its “eStore,” Shuren said, adding that there is no special software required.

Also in 2021, Shuren said CDRH will finalize its guidance on patient-reported outcomes (PROs) to make sure studies are measuring the things that really matter to patients. “We are seeing more and more clinical studies for devices using these PROs, and not just to gather information, but becoming secondary and primary endpoints,” he said.