- Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, and medical device industry representatives responded to questions from Congress about the fifth Medical Device User Fee Amendments (MDUFA), which would set the FDA performance goals and how much it can bring in through fees over the next five years.
- Congress must renew the agreement before the end of September, when the current version expires. Multiple lawmakers asked the FDA why it had missed its deadline for the agreement by more than two months. Rep. Frank Pallone, D-NJ, said that the deadline "is not a mere suggestion; it's actually the law," noting that it was important to have time for the agency, industry and members of the public to thoroughly review the recommendations.
- During the Wednesday hearing, the House Subcommittee on Health also raised questions about specific provisions of the agreement, including how CDRH planned to meet its hiring goals, which will be tied to specific incentives, and whether the agency's workload will be sustainable as the number of submissions increases. The agreement is expected to bring in a minimum of $1.78 billion between 2023 and 2027, which could increase to $1.9 billion if the FDA meets certain performance goals.
Shuren repeatedly apologized for the FDA's lateness in getting MDUFA V to Congress, chalking it up to pandemic delays and differing opinions across industry stakeholders.
"The medical device industry is very heterogeneous and it has very diverse opinions. That can take time to work through. Regardless, we should have had that on time," Shuren said during the Wednesday hearing.
Rep. Anna Eshoo, D-Calif., who chairs the House Subcommittee on Health, also shed some light on the schisms between large and small medical device companies.
"They did not see eye to eye. It's not a surprise because each one has its own self interest. That took time as well," Eshoo said.
After the FDA and industry missed the original Jan. 15 deadline, it became clear that they had encountered some "roadblocks" in the negotiations. However, with no meeting minutes since June of 2021, it's difficult to know exactly what those discussions entailed. Rep. Cathy McMorris Rodgers, R-Wash. noted this, saying she had raised "serious concerns about the lack of transparency throughout this process."
When asked, Shuren estimated more than a dozen meetings had taken place since last June.
"I have to tell you, negotiations on MDUFA, it's more like an international treaty. Lots of parties, lots of perspectives," Shuren said. "And the same happens with the meeting minutes, there's a lot of back and forth on them … everyone wants to be comfortable with what's in there."
A growing workload
During the hearing, Shuren pointed to the growing volume of the agency's work, both before and during the COVID-19 pandemic. During MDUFA IV, over the last five years, the agency received 3,000 more presubmissions than it was resourced to review.
Since 2018, the agency has granted more than 600 breakthrough device designations. And since the start of the pandemic, it has received more than 8,000 requests for emergency use authorizations and pre-EUA requests. So far, it has granted EUAs to more than 2,200 devices for COVID-19.
"The magnitude of the emergency response inevitably led to a backlog and delayed review times," Shuren said.
The FDA has reduced the backlog of non-COVID device submissions, and plans to be mostly back to normal operations later this year. It still continues to get roughly 130 new EUA requests per month, Shuren said. In the meantime, the agency has instructed device-makers that currently have an EUA to "go ahead and get in line" to seek full authorization.
So far, industry generally seems to be supportive of the MDUFA V agreement, including measures that tie performance goals for the FDA to funding. Janet Trunzo, executive vice president of technology and regulatory affairs for AdvaMed, spoke favorably about the agreement before Congress, adding that the medtech lobby believes the package would provide more resources and capacity for the FDA, as well as greater predictability for industry.
However, the incentives also raised some questions from Congress. Rep. Debbie Dingell, D-Michigan, asked whether the new performance incentives would present any risk that speed could have a negative impact on the quality of premarket review.
Shuren responded that this wasn't a concern, adding that increased FDA staffing would give people more time with each file.
"That's not taking away from their ability to identify deficiencies and communicate this," Shuren said.
New advisory program
The MDUFA V agreement also includes a new total product lifecycle advisory program (TAP), which is expected to launch in a small, 15-product pilot next year. It's intended to foster earlier and more frequent communication between product sponsors and the agency.
Legislators asked questions about what differentiates this new program from the FDA's pre-submission program, and how the agency would ensure that it doesn't divert resources away from other important programs.
Shuren said the new TAP program was different in that it provided an opportunity for the FDA to work with developers to answer questions in a more fluid, back-and-forth manner, saving developers months or years in the process. Shuren added that the agency should have more resources because of the new incentives, but can scale back the number of products coming into the pilot if it underestimates its resource needs.
Finally, there was some discussion during the meeting over whether the FDA needed to better define remanufacturing, after the agency put out a draft guidance last year to distinguish between device servicing and remanufacturing, and a proposed bill also seeks to update the definition.
Lawmakers asked whether there is a need to redefine the term "remanufacturing," which device makers say would improve safety and device performance.
The Medical Imaging & Technology Alliance (MITA) issued a statement in support of the proposed bill, while consumer lobbyist Public Interest Research Group said it would increase costs and lead to service delays by including some repairs under the definition.
Diane Wurzburger, executive of regulatory affairs for GE Healthcare, said more clarification is needed and "there is value to providing greater clarity via statute."
Shuren made similar comments, noting that "there is value for providing greater clarity and maybe even doing so through statute with further expansion than through guidance. When we saw reports come in where there were allegations about problems with servicing, most of those turned out to be remanufacturing."
A clarification could potentially be added to MDUFA, although lawmakers spent most of their time discussing the FDA guidance and the proposed bill.