Public Comment of Generation Patient, National Center for Health Research, Patient Safety Action Network, and USA Patient Network in response to the Medical Device User Fees Amendments (MDUFA) VI Stakeholders Process and Commitment Letter

August 7, 2026

Re: Docket No. FDA-2026-N-6655 for “Medical Device User Fee Amendments; Public Meeting; Request for Comments.”

We appreciated the opportunity to participate in the MDUFA Stakeholders meetings. As representatives of patient, consumer, health, and public interest organizations that do not receive funding from medical device companies, we are providing this comment to reiterate the mutual priorities that we expressed at the Stakeholders meetings in light of the MDUFA Commitment letter.

We appreciated the many presentations by FDA staff but were disappointed with the limited time allotted to ask clarifying questions and to discuss our priorities and concerns. The minutes of FDA’s meetings with industry were not detailed and generally did not reflect successful negotiations regarding our strong recommendations that, similar to the arrangement for PDUFA, user fees be available to improve post-market surveillance and that performance goals include metrics that reflect safety and efficacy goals. The fact that negotiations between CDRH and industry were apparently completed in record time and specifically rejects the proposal to support some post-market surveillance is consistent with our views that CDRH did not adequately represent our concerns. At one of the Stakeholder meetings we were told by the FDA staff that Industry said they would not allow user fees to be used for post-market surveillance, and that is consistent with the Commitment letter, which supports the use of real-world evidence (RWE) but only for premarket review. We point out that this makes no sense since almost all RWE is available after devices are cleared, classified, or approved for market.

At the MDUFA Public meeting held on August 4, 2025, invited speaker Dr. Diana Zuckerman of the National Center for Health Research reported that in the previous commitment letter, statements starting with “FDA will do x” or “FDA’s response letter will include y” were made more than 200 times, whereas there were just a few statements starting with FDA and industry will ___” and even fewer saying what industry needs to do.  We note that the new Commitment letter similarly states what FDA will do well more than 200 times, and again rarely specifies what industry must do.  Given that the FDA is a regulatory agency, the medical device industry should not be making almost all the decisions about what the FDA should do in order to get user fee funding.

Similarly, throughout the Stakeholders meetings for MDUFA VI, we heard that the patient and public health needs of members of our nonprofit organizations either were not acceptable to the Industry negotiators (such as supporting post-market safety reviews noted above and to support regulation of chatbots that provide inaccurate or misleading health or mental health advice rather than innocuous “wellness information”) or not under the jurisdiction of MDUFA negotiations because they were considered to represent policy issues. In contrast, it seemed that industry demands (such as harmonization with foreign regulatory agencies, U.S. device companies maintaining its leadership position, and not regulating widely used AI devices) and HHS demands (such as higher fees for foreign companies) were seriously negotiated regardless of whether they seemed to fit typical user fee topics of staffing levels in exchange for fees.

Public health indicators/measures 

During our MDUFA Stakeholder meetings, we were among many participants who urged that MDUFA Commitment Letter performance measures should include quality measures that evaluate the public health impact of the MDUFA program. We were also among the many that urged that user fees should also support staff that improve the quality of FDA reviews, not just the speed. We are disappointed to see that the Commitment letter does not include any such safety or effectiveness performance goals. Here are several examples of information that should be provided under MDUFA VI:

  1. How many of the recently considered PMA approvals were based on the gold standard of at least independent, randomized, blinded, controlled trials;
  2. What percentage of PMA applications is denied? What percentage is withdrawn prior to denial?
  3. What percentage of 510(k) applications is denied? What percentage is withdrawn prior to denial?
  4. How many trials submitted through the PMA pathway included a sufficient number of representative demographic subgroups (and statistical power) to evaluate whether benefits outweigh the risks for males and females; racial and ethnic minorities; and younger age groups that are still developing and more fragile patients (of any age, but especially young children and adults over 65);
  5. How many clearances, DeNovo classifications, and PMA approvals resulted in recalls, warnings, withdrawals, safety inspections, or other key safety issues within the following 10 years after approval?  Including project codes would add important safety information.
  6. How many devices cleared through the 510(k) pathway included any meaningful clinical evidence of safety or effectivenessas described explicitly in publicly available documents? How many of those were cleared through 3rd party reviewers rather than FDA staff?
  7. Other than the NEST pilot projects, provide metrics indicating full UDI compliance delineated by product code.

Other performance measures that should be considered

  1. What proportion of devices that the FDA approved or rejected through the PMA process or classified for market under the DeNovo process were reviewed by an FDA Advisory panel?
  2. How many (number and proportion) of devices given breakthrough device designation provided data on demographic information, safety, and effectiveness results that were reported in clinicaltrials.gov and other publicly available databases or documents?
  3. Clarify the distribution of all CDRH FTEs and contractors assigned to pre-market and post-market safety and effectiveness issues, including subject matter experts. What percentage of  these funds for review of MDRs, recalls, and post-approval studies are supported by MDUFA fees?

Transparency

At Stakeholder meetings, we repeatedly requested but failed to receive specific information about financial/staffing resources needed by CDRH to achieve its mission. We also asked how much of those resources have been from user fees and from appropriations. We were not given information about which activities the Centers consider the highest priorities, so were unable to share our views of those priorities.  We are pleased to see there will be efforts to increase software and AI subject matter experts but have no information about the specific numbers of those experts now or specified under MDUFA VI. This lack of transparency is unfair to Stakeholders. Here are examples of the types of information that we requested that were not made available during Stakeholder meetings:

  1. How many subject matter experts (FTE) has CDRH had on staff in January of each of 2024, 2025, and 2026, and how many of these were software experts, including AI.  How many of these positions were staffed by user fees?
  2. How many staff supported by user fees vs. appropriation funding conduct facility inspections and what proportion of inspections are done as frequently as required?
  3. How many staff paid by user fees vs. appropriations review Direct-to-Consumer ads?

Other Issues

Stakeholders raised the issue of clinical representation and lack of age-specific post-market data of underrepresented age populations, including young adults (>18) and patients over 65. FDA should ensure data collected from clinical trials and post-market surveillance is properly disaggregated by age subgroups and publicly reported (including on the Adverse Event Monitoring System (AEMS).

Concerns about New Commitment Letter Requirements for FDA

At MDUFA Stakeholder meetings, we repeatedly emphasized the patients’, consumers’ and public health experts’ lack of a voice in the MDUFA process because Stakeholders are not included in the FDA-Industry MDUFA meetings or at least be able to watch the meetings remotely in real time or videos of those meetings. Stakeholder organizations should have the opportunity to directly share their views in meetings with the FDA and industry. Instead, CDRH staff have told us that Stakeholder meetings with the FDA intended to provide us with sufficient input.

Unfortunately, despite hours spent sharing our views at this meeting, the Commitment letter does not reflect the priorities we discussed at our Stakeholder meetings, and minutes of the FDA-Industry negotiation meetings provide no evidence that most were discussed. This letter is an additional effort to seek meaningful input prior to the commitment letter being finalized.

As noted above, we are pleased that the Commitment letter includes increases in subject matter experts, but it unfortunately includes numerous examples that directly conflict with the concerns we expressed at Stakeholders meetings.  For example:

Real World Evidence

Real world evidence for medical devices relies on patients in clinical practice who use those devices and whose billing records or electronic health records can be used to provide information about the safety or effectiveness of those devices. The best use of RWE by the FDA requires that the devices be legally on the market in the U.S. and that they be studied on U.S. patients for the indications specified on the label, since non-U.S. patients, or patients using products illegally or off label could not be assumed to be representative of U.S. patients using a product that is legally on the U.S. market for the studied indication. Any RWE used to support FDA regulatory decisions should be demonstrated to be fit for purpose, relevant to the specific regulatory question, and sufficiently reliable to support valid conclusions about a device’s safety and effectiveness. It is therefore inappropriate that the Commitment letter specifies that:

  1. “The Agency will use user fee revenue for the continued development of Real-World Data (RWD) and RWE methods and policies to advance regulatory acceptance for premarket submissions, including expanded indications for use of market authorized products, market authorization of new devices and market authorization of modifications or new features for market authorized devices” and that “User fee revenue intended for RWE shall be devoted solely to advancement of premarket uses.”
  2. “By December 31, 2027, in collaboration with National Evaluation System for health Technology (NEST), FDA will update stakeholders on how the “NEST Mark: Real-World Data Sources” (hereinafter “NEST Mark”) and its application to NEST RWD/RWE contained in Data Sources can be used to support premarket submissions.”
  3. FDA will continue to advance CDRH’s RWD/RWE Training program for FDA review teams including the medical review staff. Topics will include best practices for RWE review, differences in conduct and scientific methodology between prospective clinical trials and RWE studies, and when to engage with CDRH RWE subject matter experts.

As stated earlier in this letter, we were among the many MDUFA Stakeholders that strongly recommended that user fees be used for post-market surveillance, given the lower standards for getting devices on the market, compared to prescription drugs and biologics. Claims data and electronic health records may not capture device-related adverse events, patient-reported symptoms, complications when patients receive treatment at a different hospital, clinic, or health system from where the device was implanted or prescribed, particularly when those records are not linked. In fact, patient testimony at numerous CDRH Advisory Committee meetings clearly shows that patients’ adverse events are often not captured on either claims data or EHR. While we would support the use of appropriately evaluated RWE for post-market surveillance, we find the staff time needed for the Commitment letter focus on RWE for premarket applications to be illogical and not scientifically valid, for the reasons specified above.

Deficiency Letters

We understand that it is appropriate for industry to have clear information about deficiencies in their applications, so that they can improve their submissions in the future. However, the new requirements in the MDUFA VI Commitment letter require considerable extra work for FDA staff, requiring additional specificity in the deficiency letters, allowing companies more opportunity to challenge deficiency letters without reapplying, requiring FDA to provide additional training to FDA staff regarding deficiency letters, requiring an annual audit, and requiring the FDA to develop a well-designed survey that the FDA must distribute and analyze annually. This will require a great deal of time from FDA staff  that would be likely to take them away from other important review efforts. For example, the FDA must provide:

  1. Detailed explanations of application deficiencies in writing: “FDA will provide a statement of the basis for the deficiency, consistent with the current guidance, in deficiency letters for 95% of deficiencies each fiscal year for Original PMA, Panel-Track Supplement, 510(k) and De Novo request submissions. Performance will be determined by means of annual audit conducted by QMOE.”
  2. An annual survey “for recipients of deficiency letters to gather feedback and a review of each fiscal year’s deficiency audit results and improvement subject to the MDUFA goal by September 30, 2029. The purpose of the survey will be to gather feedback on deficiency communication. When developing the survey, FDA will seek input from and discuss with industry the planned sampling methodology.’
  3. “FDA will review each fiscal year’s deficiency audit results and improvement activities with industry no later than the first quarterly meeting of the following fiscal year.” In addition to the amount of staff time required that would take away from other important staff responsibilities, these additional requirements regarding deficiency letters could serve as a disincentive to reject deficient applications, since doing so would be much more time-consuming than approving and clearing products for market despite deficient applications.

Thank you for the opportunity to share our views.