The health subcommittee of the House Energy and Commerce committee met this week to question Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, about the medical device user fee amendments (MDUFA).

MDUFA is an agreement between the FDA and industry in which the FDA agrees to do certain things in return for industry groups supporting the agency’s work by paying fees to put their devices through regulation. Of particular interest to MobiHealthNews readers, Shuren dove into the ways in which the FDA has committed to reorganize to better centralize its digital health operations as part of its end of the bargain.

“One of the key components of the MDUFA 4 reauthorization would be to establish a digital health unit within the center to help drive coordination and consistency,” Shuren told the committee. “The way we’d set this up is our review staff, who deal with software as a medical device, they’ll get basic training. They’ll sort of be the yellow belts: they’ll deal with more general issues. Then within the offices we’ll have better trained people, you know, the green belts. And you can think of this digital health unit, these are the black belts who get involved in the more challenging submissions who can oversee training and ensure consistency.”

The agreement must be renegotiated and reauthorized by Congress every five years, and the deadline for MDUFA 4 is September 30th of this year. The last reauthorization happened in 2012 with the passing of the Food and Drug Administration Safety and Innovation Act (FDASIA).

“FDASIA included meaningful regulatory reforms, improved communication between industry and FDA, and increased accountability at the Center for Devices and Radiological Health,” Representative Michael Burgess (R-Texas), who chairs the subcommittee, said in a statement. “It is important that the next medical device user fee agreement continue to build upon the progress made in FDASIA, as well as the good policies members of this subcommittee championed in the 21st Century Cures Act. I am encouraged that the proposed agreement transmitted to Congress in January contains many promising elements that will be good for FDA, industry, and most importantly, patients.”

Shuren began by sharing some highlights of what the agency was able to accomplish under MDUFA 3. 

“Changes we have made at the CDRH to our culture, our policies, and our processes; the investments provided by industry through user fee funding; and the direction provided by Congress through changes to federal law have resulted in an improved medical device pipeline and innovative technologies being introduced in the US earlier than in the past,” Shuren said in his opening remarks. “In fact, the number of novel devices we’ve approved has almost quadrupled, from 24 in 2009 to 92 in 2016, the highest since the start of the user fee program in 2003.”

Without actually naming the company involved, Shuren also highlighted the work the FDA has done in getting the Dexcom G5 approved for nonadjunctive use, saying the agency helped the company bring the technology to market years earlier than intended.

Another part of changing how the agency regulates digital health is FDA’s continued participation in the International Medical Device Regulators Forum.

“Part of this agreement is to continue our international harmonization work in the IMDRF, which is critical in harmonizing international regulation, but also in changing the paradigm,” Shuren said. “We’re looking at changing the paradigm of software as a medical device to better meet the rapid innovation cycles we see in these technologies, and we’re working collaboratively with others to create that new paradigm.”

In addition to the digital health material, Shuren discussed other provisions of the amendment, which include increased focus on patient engagement and feedback and continued use of real world evidence in device approval and relabeling. Much of the FDA’s work in real world evidence is through an initiative called National Evaluation System for health Technology, or NEST.

“One of the great inefficiencies of our healthcare system is we gather information every single day in patient encounters but we can’t make great use of it, because it might not be standardized, it might be incomplete, it might be of poor quality, and it sits in electronic health records and payer claims,” Shuren said. “What NEST is about is how do you use market forces, how do you use the collective purchasing power of the ecosystem to drive toward greater standardization and consistency, drive down the time and cost of being able to leverage that information, and then use it to inform decision making, to generate the evidence to come to market, as well as to meet post-market requirements?”

Patient engagement commitments in MDUFA include the creation of a patient engagement office, something the FDA has already begun working on and even opened up for public comment.

“One area we’ve decided to focus on is ‘How do you better understand the perspectives of patients?’” Shuren said. “You can ask people, but in a patient population they self-stratify. So we’ve been examining the the science of patient preference. What are the tools you can use to more quantitatively assess tradeoffs patients are willing to make?”

While MDUFA seems very likely to pass, it clashes with somewhat confusing language in President Trump’s skinny budget that suggested the president wants higher fees to bring in more money for the federal government, something that could potentially hamper small companies.

The Trump budget wasn’t really discussed at the hearing yesterday, but Shuren did respond to a question about what would happen at the FDA should MDUFA fail to pass for whatever reason.

“In terms of what happens if we’re not able to reauthorize MDUFA4, we’re going to lose a third of our staff immediately and we’ll see more that leave afterward,” he said. “Not only would we not be able to make good on our current MDUFA commitments, those would sunset, but just running the program to do anything is going to be challenging.”