MedCon: Shuren updates on MDUFA V, TAP, health equity

COLUMBUS, OH – The US Food and Drug Administration’s (FDA) device center is continuing to “turn the ship around” and away from work done during the COVID-19 pandemic while also focusing on safety and innovation, as well as facing evolving challenges.

That starts with focusing on the patient, Jeff Shuren, director of FDA’s Center for Devices and Radiological Health (CDRH), told attendees at the 2024 MedCon conference, sponsored by the AFDO/RAPS Healthcare Products Collaborative and FDA.

“At the end of the day, it’s critically important that people have timely access to high quality, safe, and effective medical devices,” he said. The CDRH’s goal of giving patients in the United States (US) “first in the world” access to medical devices means timely access, rather than a race to be the first country to bring a device to market.

“We are not in competition with other countries. In fact, it is a value to us that important technology is available not just in the US, but in other countries in and around the same time,” he said. “We'd like to see those benefits for people across the globe.”

One of Shuren’s priorities when he joined CDRH in 2009 was to change how innovators tended to skip over the US when seeking approval for novel devices. In 2023, there was a fivefold increase in the number of novel device authorizations when compared to 2009, he noted, with many of the novel devices coming out of the COVID-19 pandemic.

Concerning breakthrough devices, the agency typically grants more than 100 devices each year with a breakthrough designation. “Most of the submissions that come in for novel technologies, we ultimately authorize,” Shuren said. “But here's the sad truth. The majority of devices that get a breakthrough device designation never get to patients, even if they might have been safe and effective.”

Factors “beyond the FDA” can impact these technologies and prevent them from coming to market, Shuren said. These can include the value proposition not being well understood, and not understanding what evidence patients and providers need to adopt and use new technologies, as well as coverage and reimbursement from payers.

MDUFA V

FDA is continuing to work towards meeting its commitments under the Medical Device User Fee Amendments (MDUFA V) program, Shuren noted. “So far, we are either meeting or on track to meet all of our performance goals,” he said. “So right now, the lights are green and looking good.”

One area FDA is working towards improving is communication surrounding deficiencies in premarket submissions. Shuren said FDA hasn’t been doing a great job communicating its rationale to companies for identifying a deficiency. However, the agency is getting better, he said, and has created training, tools, and liaisons around supportable rationales for identifying deficiencies. The ultimate goal would be to not have any deficiencies in the first place, he said.

“I'll tell you from my staff, one of the most frustrating things they deal with—and it impacts our morale—is when they have submissions that are poor quality, and there are a lot of problems in there,” Shuren explained. “We get a high-quality submission, we’re not dealing with a whole bunch of deficiencies. It is a better experience for us, it’s a better experience for the sponsor, and it's just a better win for patients at the end of the day.”

FDA is also meeting all of its current goals with the Total Product Lifecycle Advisory Program (TAP) program, Shuren said. Under TAP, 43 devices have been enrolled as of 12 April, which includes 23 devices in the Office of Cardiovascular Devices, Office of Product Evaluation and Quality, and 18 devices in the Office of Neurological and Physical Medicine Devices, Office of Product Evaluation and Quality.

“We're going to continue to expand the program over the course of MDUFA V,” Shuren said.

Companies are finding value in engaging with TAP advisors, he noted, referencing one company that claimed to save a year of development time after several meetings with advisors. “That is a real game changer for innovators, and that’s what TAP is about,” Shuren said.

Health equity

Shuren said technology is “the bridge” to help achieve CDRH’s strategic priority of advancing health equity. “Healthcare costs are going up, and this is untenable at the end of the day,” he said. “We can do a lot better.”

This includes a focus away from healthcare facilities in the US as the number of providers continue to shrink, and a shift towards using the patient’s home as a healthcare hub. The agency recently launched the Home as a Health Care Hub initiative to help facilitate this change.

“Even from a business sense, this idea of moving care to the home … wherever the person is, is really the way to go from our perspective,” Shuren said.

MedCon: Shuren updates on MDUFA V, TAP, health equity

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