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 for Dr. Diana Zuckerman, President, National Center for Health Research, to serve on the patient and consumer panel at the MDUFA VI meeting on August 5, 2026, and want to more fully explain some of the issues she raised regarding the Commitment Letter. As she noted, we greatly appreciate that Dr. Tarver and the FDA staff who negotiated have made clear their commitment to patients’ voices and patient safety, but the Commitment Letter does not reflect that commitment. Instead, the MDUFA VI Commitment Letter specifies well more than 200 requirements that the FDA must do, a few dozen that medical device companies must do (including some that are joint responsibilities of industry and CDRH), and just a handful of vague mentions of safety or effectiveness.
Deficiency letters:
This section of the Commitment letter requires a great deal of staff time that is clearly disproportionate to the sponsors’ responsibilities. Over the years, we’ve seen numerous examples of where medical device companies provided obviously inadequate or flawed evidence of substantial equivalence or clinical benefit. In some cases, the sponsor did not follow CDRH published guidance or other clear suggestions of the type of evidence that would be most likely to result in approval, clearance, or certification. In those cases, it should be sufficient for a deficiency letter to briefly explain why the application was deficient (perhaps just a checklist) and not be required to justify the decision in detail, let alone have to be included in an audit and an annual survey designed to obtain feedback from the companies receiving those letters. The responsibility should not fall primarily on FDA reviewers to repeatedly explain deficiencies that could have been avoided if sponsors had followed existing FDA guidance and recommendations. Instead, MDUFA should place greater responsibility on sponsors to submit complete and scientifically adequate applications and not waste FDA staff time defending clear shortcomings in those applications, creating a disincentive for FDA staff to require appropriately high standards. For straightforward deficiencies, a concise citation to the applicable regulation, guidance, recognized standard, or other previously communicated FDA recommendation should be sufficient. This would allow FDA reviewers to devote more of their limited time to thorough reviews aimed at determining whether medical devices are safe and effective.
Clinicaltrials.gov
As part of industry’s responsibilities, the Commitment letter should state that companies will register any relevant clinical trials on clinicaltrials.gov at the time the studies are initiated, and provide meaningful, detailed data about benefits and adverse events when the study is completed. This should be included in clinicaltrials.gov before the product can be marketed. It is unfair to patients and to competitors to sell medical devices without providing their detailed clinical trial data on clinicaltrials.gov. As we stated at the MDUFA meeting on August 5, our analysis of breakthrough devices found that several clinical trials that were described in application materials to CDRH were not registered in clinicaltrials.gov, and numerous breakthrough devices that were already on the market and that had been registered on clinicaltrials.gov did not include the results of the trial or trials, even though the breakthrough devices were already on the market. Unfortunately, many of those that did have results included on clinicaltrials.gov had summarized the results in rather general terms rather than providing data on benefits and adverse events. Moreover, many results did not provide demographic information such as ages, sex, and race.
These shortcomings in publicly available information make it much more difficult for patients, physicians, researchers, and other device companies to evaluate the evidence supporting devices that are already being used in clinical practice. The MDUFA Commitment letter should therefore make timely and complete clinical trial registration and results reporting an explicit industry responsibility. At a minimum, reported results should provide enough information to evaluate benefits and adverse events and to determine whether outcomes differ among the types of patients (such as age and sex) who were studied.
Post-market data support from user fees
We were pleased that the panel members agreed about the importance of post-market data and evidence, which remains a major shortcoming of MDUFA VI. Stakeholder recommendations that MDUFA include post-market support was a major theme of the MDUFA VI Stakeholder meetings. We have worked with thousands of patients in our 27 years as a nonprofit research center, and the lack of clear, objective information about evidence regarding benefits and adverse events is patients’ greatest frustration. Patients (and their doctors) want and deserve information that can help them make informed decisions prior to using a medical device and help them determine the best medical solution if adverse events occur or if an implanted device is likely to fail in the future. Patients desperately need post-market evidence, whether from FAERS, AEMS, registries, or other RWE, and the medical device industry should show their commitment to patients and physicians by agreeing that user fees should support staff to add to post-market surveillance resources provided by federal appropriations. Instead, MDUFA VI only mentions post-market activities when it explicitly states that user fee revenue intended for RWE “shall be devoted solely to advancement of premarket uses.” We strongly recommend removing that restriction and allowing a meaningful portion of user fee funding to strengthen post-market evidence and surveillance.
Since premarket device applications provide much less evidence than those for CDER and CBER, post-market systems are essential for identifying problems that were not apparent when a device went on the market and for providing patients and physicians with evidence of safety and effectiveness over the device’s lifetime.
In addition, as part of MDUFA, industry should work with CDRH to help ensure that registry data are available to CDRH, and not controlled by medical societies or other entities that receive funding from device companies. CDRH access to those data should not depend on the cooperation of outside organizations or entities. CDRH should have timely access to sufficiently detailed registry data needed to independently evaluate device performance, adverse events, and emerging safety concerns and should make this important information available to the public. In these ways, the MDUFA Commitment letter would reflect the commitment of CDRH and the medical device industry to helping patients and physicians make informed decisions and maximize the benefits of medical devices.
Conclusions
We urge FDA and industry to revise the MDUFA VI Commitment Letter so that its requirements better reflect the shared responsibility for ensuring that medical devices are safe, effective, and supported by transparent evidence. User fees have succeeded in reducing review times dramatically and should now also focus on ensuring that FDA staff have the resources needed to ensure the quality of medical devices on the market and making essential information available to patients and medical professionals. The changes we recommend would help ensure that CDRH has the resources and support needed to carry out its essential responsibilities to patients while MDUFA also serves the needs of medical device companies.
Respectfully submitted,
National Center for Health Research,
Washington, D.C.