U.S. companies will face fewer changes under the new Medical Device User Fee Amendments (MDUFA), but overseas companies will face higher costs than under the current five-year agreement.

The MDUFA negotiation process between the FDA and the medical device industry determines the amount of medical device fees the agency can collect from 2028 to 2032.

At a public meeting on Wednesday, industry leaders broadly supported the latest agreement, MDUFA VI, while patient groups called for more attention to post-market safety.

Fee increases for overseas companies

FDA Acting Commissioner Kyle Diamantas said that user fees paid annually by medical device companies will remain relatively stable, and some U.S. companies may even see reductions. This adjustment is balanced by increasing fees for overseas companies. Small business fee exemptions will be limited to U.S. companies, and the FDA's Center for Devices and Radiological Health (CDRH) has proposed raising establishment registration fees for foreign companies to cover higher costs related to inspections and imports.

Eli Tomar, Deputy Director of the CDRH Office of Policy, noted that the entire package totals approximately $580 million per year, an increase of about 1.5% over the baseline.

AdvaMed, a medical device lobbying group, expressed support for the new agreement. Zach Rothstein, Executive Vice President of AdvaMed's Digital and Diagnostics Technology division, said the trade organization "strongly supports" MDUFA VI, adding that the agreement maintains stable fee levels and focuses on strengthening existing programs rather than launching new initiatives.

Review goals unchanged

The FDA's time goals for making decisions on device clearance or approval remain unchanged. However, the agency has added a new "focused follow-up" option for premarket submissions, allowing companies to send questions within 45 days after a recent pre-submission.

No mandatory hiring requirements, but increased transparency

The latest agreement abandons the hiring targets from MDUFA V but will regularly report CDRH staffing levels and new hires. This reporting requirement comes after the Trump administrationlaid off thousands of FDA employeeswith little notice or explanation.

Mark Leahey, CEO of the Medical Device Manufacturers Association (MDMA), said the trade organization had hoped for more personnel working on premarket review at this time. Leahey noted that in recent years, "the net increase in CDRH staff dedicated to the device review process has actually declined, but we have no way to access that information." He added that more public reporting would benefit everyone.

TAP program made permanent

The Total Product Life Cycle Advisory Program (TAP), piloted under MDUFA V, will become a permanent program with a clear scope. The program aims to provide innovative medical devices with opportunities for early and frequent communication with the FDA and to assist in designing studies so that device companies can generate the evidence needed by payers such as Medicare.

Diana Zuckerman, president of the National Center for Health Research, emphasized the importance of representative groups in clinical trials and noted that people with chronic disabilities are often underrepresented. She said, "We know many device companies are frustrated that their products are not automatically covered by Medicare, but we also know that if a device has no clinical trials, or trials that do not include people over 65, it is difficult for Medicare to determine that the device is reasonable and necessary."

Real-world evidence and representative data

The new agreement expands the use of real-world evidence, which can include data from insurance claims, health records, and wearable devices. The FDA also plans to support the use of technology to recruit patients representative of the intended use of devices for clinical trials.

Patient groups and digital health advocates said real-world evidence should be used not only in premarket review but also in evaluating devices after they reach the market. Zuckerman said, "The best data on real-world evidence comes after the fact, not before." She called on the FDA to reconsider this measure. Benjamin Vandendriessche, Chief Scientific Officer of the Digital Medicine Society, also called for the use of real-world data in the post-market setting.