Medical device industry leaders expressed broad support for the proposed MDUFA VI agreement, while patient groups called for greater focus on device safety after products reach the market. The agreement sets the amount of fees that the U.S. Food and Drug Administration (FDA) may collect from medical device companies during the period from 2028 to 2032.
This came during a public meeting held by the agency to discuss the agreement, which is still under review. The FDA will accept comments through the end of 2026 before planning to submit the final package to Congress in January 2027, with the government expected to approve the new budget by September 2027.
Higher Fees for Foreign Companies
Acting FDA Commissioner Kyle Diamantas said annual fees would remain relatively stable or could decline for some U.S. companies. Foreign companies, by contrast, will face cost increases, while small-business fee waivers will be limited to U.S. companies.
The agency’s Center for Devices and Radiological Health proposes raising establishment registration fees for foreign companies to cover higher expenses associated with inspections and imports. The total package is worth approximately $580 million annually, an increase of about 1.5% over the baseline, according to Eli Tomar, deputy director of the center’s Office of Policy.
Advamed, a group representing companies in the sector, announced its strong support for the agreement. Zack Rothstein, the group’s executive vice president for digital technologies and diagnostics, said MDUFA VI maintains stable fee levels and focuses on strengthening existing programs rather than launching new initiatives.
No Change to Review Goals and Greater Staffing Transparency
The timelines set for the FDA to make decisions on device clearance or approval will not change. However, the agreement adds a dedicated follow-up option for premarket submissions, allowing companies to submit questions within 45 days of a prior meeting or action related to the pre-submission.
The agreement also abandons the specific staffing goals included in MDUFA V, but requires periodic reports on the number of employees and new hires at the Center for Devices and Radiological Health. This follows a year in which the administration of President Trump cut thousands of FDA employees with little notice or explanation, according to the article.
Mark Leahy, president and CEO of the Medical Device Manufacturers Association, said his group had hoped to increase the number of personnel conducting premarket reviews. He added that net new hiring in the center’s device review program had declined in recent years, with no clear mechanism for making this data available.
Turning TAP into a Permanent Initiative
The agreement provides for converting the Total Product Life Cycle Advisory Program, known as TAP, from a pilot program launched under MDUFA V into a permanent program with a revised scope. TAP aims to enable early and frequent communication with the FDA for developers of innovative medical devices, and also helps companies design studies that provide the evidence sought by healthcare payers, such as Medicare.
Diana Zuckerman, president of the National Center for Health Research, emphasized the importance of representing different groups in clinical trials, noting that people with chronic disabilities are often inadequately represented. She said that the absence of clinical trials, or the failure to include people over age 65 in them, makes it difficult for Medicare to justify covering a device as medically necessary and reasonable.
Debate Over Real-World Evidence
MDUFA VI expands the use of real-world evidence, which may include insurance claims data, health records, and wearable devices. The FDA also intends to support the use of technology to recruit participants who represent the intended use of the device in clinical trials.
However, patient groups and digital health advocates called for real-world evidence to also be applied to the review of devices after they are marketed, rather than being used only before marketing. Zuckerman said the best real-world data are collected after a device is marketed, while Benjamin Vandendriesch, chief scientific officer of the Digital Medicine Society, called for the use of real-world data in the post-market phase.