Patient groups called for substantial changes to medical device user fees in comments submitted to the Food and Drug Administration. Negotiations recently kicked off for the medical device user fee amendments, which will determine how much funding the FDA’s device center can collect from the industry in fiscal years 2028 through 2032.
After a public hearing last month, clinicians and patient groups submitted comments calling for an increase to user fees, bolstering FDA staffing and more emphasis on product safety. They also called for greater transparency around negotiations and for patients to have more input on the final agreement.
The FDA received a total of 27 comments by Sept. 4, including several submissions from patients and medical groups. Two large medtech industry lobbying firms, Advamed and the Medical Device Manufacturers Association, which had opposed user fee hikes in the public hearing, had not posted comments as of Thursday.
The case for raising user fees
Nonprofits called for an increase in user fees to support staffing and safety efforts at the FDA’s Center for Devices and Radiological Health. User fees supplement congressional appropriations, but still make up a substantial portion of the device center’s budget. For fiscal year 2026, CDRH has a budget of $883 million, with nearly half, or about $428.1 million, coming from user fees.
Current 510(k) fees are too low to support thorough reviews of most devices, the National Center for Health Research, a nonpartisan think tank, wrote in a Sept. 4 letter. The FDA charges $24,335, or $6,084 for small businesses, under the current agreement.
Although medical device user fees increased substantially in the last five-year agreement, they are still “a tiny fraction of the fees charged for drug applications,” the nonprofit wrote. The National Center for Health Research recommended the FDA increase fees for large, multinational companies and use stricter criteria for which companies qualify for small business fees.
Staffing concerns
Several commenters raised concerns about a shortage of subject matter experts at the FDA and a workforce slashed by the Trump administration. An analysis by ProPublica found that the CDRH has lost about 22% of its staff since January. The latest round of cuts in April included people who work in communications, regulatory programs and administrative services, according to reporting by MedTech Dive.
Another big area of impact was pediatrics. The reduction in force “eliminated all dedicated staff positions supporting pediatric device work,” the American Academy of Pediatrics wrote in a Sept. 4 letter. AAP called for the CDRH to rebuild its pediatric program.
Even before this year’s mass layoffs, the CDRH had a shortage of subject matter experts in areas including software, cybersecurity, biocompatibility, electrical safety and performance testing, wrote the Patient Consumer and Public Health Coalition. The group, representing more than 30 nonprofits including Doctors for America and the Cancer Prevention and Treatment Fund, said the CDRH also lacked compliance staff to ensure devices on the market are safe and effective.
“Due to the shortage of SMEs, medical device submissions were often reviewed by staff who had little-to-no expertise in many or any of the subject areas,” the coalition wrote.
As the FDA promotes the use of AI tools to help reviewers be more efficient, the coalition cautioned that AI can be inaccurate or misleading, and that any use of the technology in regulatory review must include independent evaluation and human oversight.
Review deadlines under the current MDUFA agreement were insufficient, even prior to the recent mass layoffs, another commenter, Rachel Weintraub, wrote in an Aug. 28 letter. Contractors served as subject matter experts, but many were cut in 2024, and the remainder were cut in July 2025, wrote Weintraub, who worked at the FDA in 2023 and 2024 and was a lead reviewer at the CDRH, according to the letter. As a result, lead reviewers who could not find a subject matter expert to help them were expected to review those sections themselves, even if they didn’t have the relevant expertise.
“Each of us typically had up to 11 review assignments in our queue at a time,” Weintraub wrote.
“With the 2025 mass layoffs in the FDA, which appear to be ongoing, this situation has likely gotten exponentially worse.”
Weintraub called for the CDRH to be fully staffed with the necessary expertise and for reviewers to have the option to extend deadlines as needed.
Emphasis on safety
While the past MDUFA agreement laid out review times and staffing metrics, patient groups called for more of a voice in negotiations and a greater emphasis on safety.
The current agreement, MDUFA V, “heavily prioritizes efficiency and transparency over safety and effectiveness,” Weintraub wrote, adding that the latter should be the FDA’s primary concern.
Weintraub recommended extending user fees to cover postmarket surveillance and compliance. Companies are not conducting effective surveillance and are underreporting concerns, Weintraub wrote.
“For example, as a Lead Reviewer, I observed back-to-back issues with a device company involving insufficient purchasing controls, which resulted in two Class I recalls,” Weintraub added. “Manufacturers were making changes to the devices’ designs, materials, and manufacturing methods without the company’s knowledge, because there was no oversight from the company.”
Generation Patient, a nonprofit representing young adults living with chronic medical conditions,
also called for better postmarket surveillance and adverse event reporting, citing a 2018 analysis by the International Consortium of Investigative Journalists that found medical devices were potentially the cause of over 1.7 million injuries and 83,000 deaths in the U.S.
Generation Patient said the CDRH should make its adverse events program more patient and provider friendly, require demographic data to be included in reports and require unique device identifiers. In addition, the group asked for protections for long-term implants, including requiring manufacturers to submit longitudinal device data.
The nonprofit also called for patients to have a greater voice in user fee negotiations.
“In previous cycles, user-fee negotiations took place behind closed doors with industry representatives, and meeting minutes were not shared publicly in real time,” Generation Patient wrote. “The public, not just industry representatives, must have a meaningful voice in the MDUFA reauthorization process.”
