September 4, 2025
Thank you for the opportunity to share our views on ways to improve MDUFA. The National Center for Health Research is a nonprofit public health think tank that focuses on programs and policies that affect the safety and effectiveness of medical products. We do not accept funding from entities with a financial interest in our work, so we have no conflicts of interest.
We support the reauthorization of MDUFA, but MDUFA VI needs to be greatly improved to reflect the importance of the user fee program for the patients who pay for medical devices and want better information about the safety and effectiveness of the devices they rely on. We work closely with many patient and consumer groups that tell us that their perspective as patients with implants and other essential medical devices have been ignored for years. Our participation in previous MDUFA stakeholder meetings and our published research 1,2,3 about the lack of public data on the safety and effectiveness of medical devices and poor study design of clinical trials have not resulted in improvements. We know that CDRH has not always had the resources it needs, and our goal is to improve those resources in ways that matter to patients, healthcare professionals, and our healthcare system.
MDUFA V and all other FDA user fee commitments have been negotiated behind closed doors, with only industry stakeholders present. Patient and consumer advocates, health professionals, FDA policy experts, and public health advocates have been excluded. We’ve participated in the MDUFA briefings and meetings and appreciated the opportunity to express our concerns and to hear those of other key stakeholders, but the MDUFA V Commitment Letter was completely unresponsive to stakeholders’ recommendations and requests in both its content and its tone. For
example, statements starting with “FDA will do __” or “FDA’s response letter will include __” were made 200 times in the Commitment Letter. There were just a few statements starting with “FDA and industry will ___” and even fewer saying what industry needs to do. It did not include any statements or metrics about what industry needed to do to improve their applications or their products, and nothing that either industry or the FDA needed to do for patients,
consumers, or health professionals. None of the suggestions that had been made at Stakeholder meetings or briefings were incorporated into the Commitment Letter. We regret to say that the Commitment Letter reminded us of authoritarian parents (industry) telling their wayward children (FDA) what they need to do to get their allowance.
Our recommendations are intended as constructive advice that is consistent with the new CDRH leadership, which has emphasized the importance of patient input and device safety, and the new HHS leadership, which has promised to reduce the cozy relationship between the FDA and industry. This is the perfect time to open the negotiation process to include non-industry stakeholders who have a clear understanding of the needs of patients and health professionals and the workings of the FDA and CDRH. That change would help to ensure that stakeholders who are focused on the safety and effectiveness of medical devices will be an influential part of the MDUFA VI negotiation process.
In contrast, the MDUFA V Commitment Letter did not show an appreciation for the ways that speeding up timelines and increasing access to FDA staff throughout the application process could reduce availability of FDA staff for activities focused on improving device safety and effectiveness. Although some patients will benefit from earlier access to new devices, we know of no examples where speeding access was more important than making sure that new devices
are safe and effective in ways that benefit patients, consumers, and health professionals. When standards for safety and effectiveness are weakened due to a lack of staff and unrealistic timelines, patients and their physicians must make important medical decisions without the information that they need to make informed decisions about whether the benefits are likely to outweigh the risks for specific patients. At the same time, patients will have no legal recourse
against the responsible parties if they are harmed by devices that were reviewed through the PMA pathway or if the devices are made by overseas manufacturers.
Performance Goal Metrics
Current metrics are designed to ensure that medical device companies get what they want: 1) percentages of deadlines met and total time-to-decision, 2) rates of denials for 510(k), De novo, and PMA and 3) rates of withdrawals of existing submissions by the companies. These metrics unfairly penalize the FDA for circumstances the agency cannot control, such as an applicant’s data integrity issues, or even the companies’ decisions to ignore the FDA’s recommendations of
what information is required for a successful application. Rates of withdrawals can be influenced by companies’ poorly devised regulatory strategies, calculated risks taken by companies, as well as changes in the companies’ financial situations or readiness to start marketing their devices. Even more important, these metrics do not measure the safety and effectiveness of the devices that the FDA has cleared or approved. Such metrics could include number of recalls, post-market adverse events, and patient outcomes as determined by independent studies using real world data
or clinical trials comparing different devices.
User Fees to Improve Premarket Reviews
We’ve learned from former CDRH reviewers that for more than a year, the CDRH has lacked sufficient compliance personnel as well as subject matter experts (SMEs) with expertise in software, cybersecurity, electromagnetic compatibility, electrical safety, performance testing, and biocompatibility. User fees are urgently needed to hire additional SMEs and compliance staff, because it is impossible for reviewers to meet the deadlines imposed by MDUFA V without the additional expertise needed in those increasingly important subject areas. To keep their jobs, they
do their best to meet MDUFA timelines; this too often requires reviewing sections in which they have no expertise, skipping sections, or guessing if the information provided is adequate.
It is unrealistic to think that artificial intelligence (AI) will save substantial reviewing time. AI can be helpful for some simple tasks, but it can’t be trusted to provide accurate information. Therefore, AI work products will need to be carefully vetted by reviewers to ensure that its analysis of the submission and its application of the regulatory framework is accurate and consistent with FDA policies and the public’s health.
We urge CDRH to consider other strategies to help reduce reviewing times while also improving the quality of medical devices. For example, we’ve learned that reviewers spend inordinate amounts of time reviewing applications that mention and contain information for unrelated devices that is not applicable to the subject device, or applications that have been poorly translated into English. We urge that reviewers should have the authority to require that those
applications be revised and resubmitted and/or that the FDA extend deadlines for submissions from foreign companies for applications that require additional resources due to language barriers, time differences, and the increased prevalence of data integrity issues in devices made and tested in China and India.
Falsified data in applications is also a problem that we have heard about from former CDRH reviewers, and the FDA has also acknowledged this problem in recent public communications.4 Reviewers are told they must review applications with “data integrity issues” unless they can definitively prove that they are falsified, even if it is apparent that they are. While we understand that reviewers should not make unfounded accusations, they also should not be required to spend
their time proving that data are falsified, or worse yet, spending days reviewing and clearing a medical device that they believe has falsified data. This is a situation where AI could be used to save time by helping to screen out applications. However, in cases where data integrity issues evade detection by AI, reviewers need to have the authority to quickly deny marketing authorization to those submissions.
User Fees to Support More Inspections
User fees should help pay for inspections of device manufacturing facilities, since inspections are essential to ensure the safety and effectiveness of medical devices. Inspections are essential to identify and address the risks of contamination, unreported changes that were inappropriately made to the device, or other manufacturing irregularities. The FDA has admitted that it is conducting fewer inspections than needed and that the agency has often relied on virtual inspections instead of in-person. User fees would also help recruit more investigators if the salaries could be increased to make them more comparable to reviewers, given their importance and the inconvenience of frequent travel in the U.S. and foreign countries.
Are MDUFA Fees Adequate?
Although they increased in recent years, MDUFA fees are still a tiny fraction of the fees charged for drug applications. The 510(k) fee is so low (currently $24,335, or $6,084 for small businesses) that it is not sufficient for thorough reviews of more than 96% of regulated devices. On average, these fees are too low to pay for a thorough review. To ensure there are enough staff available to conduct thorough reviews, the FDA should substantially increase the user fees for large multinational companies, making those fees more similar to PDUFA fees for comparable companies. The FDA should also eliminate small business user fees for non-U.S. companies and should create new, strictly enforced criteria to determine which U.S. companies are eligible for a small business user fee and that will help determine how much it should be increased. Of course, exceptions to higher user fees could be made when there is a shortage of medically necessary devices.
User Fees to Improve Post-Market Oversight
While PDUFA has dedicated a reasonable proportion of user fees to post-market surveillance, MDUFA has not. User fees should be made available to help pay for the FDA’s post-market surveillance and compliance review activities, as well as to help ensure that companies fulfill any post-market requirements. Although companies are required to comply with all applicable quality system regulations for the lifetime of their devices, when they fail to do so, it can take
years to remove them from the market. As shown by recalls of CPAP and BiPAP devices made by Phillips, companies may introduce revisions that are also unsafe and may respond slowly to FDA demands to fix a serious problem; this may result in patients relying on unsafe devices for months or years.
The medical device industry has successfully fought most efforts to substantially increase user fees, just as it successfully convinced Congress to eliminate a small tax on medical devices that had been signed into law as part of the Affordable Care Act (ACA). (The ACA tax was intended to help pay for insurance subsidies that make it possible for more patients to be insured, thus increasing sales of medical products.) Nevertheless, given the dramatic cuts in FDA staffing and
increase in FDA workload, MDUFA fees must be increased. In addition to the suggestions above, it would make sense to charge a separate MDUFA fee dedicated entirely to post-market reviews and surveillance. That fee would be charged at the time that a device is cleared or approved, so it would not be charged to companies whose devices were rejected by the FDA.
Post-market surveillance is especially important for implanted devices and for the many devices that use potentially toxic chemicals and particulates. Post-market user fees should support the salaries of FDA researchers needed to analyze real world data from electronic health records and registries for cardiovascular implants, joint replacements, spinal implants, and implants that have been found to cause cancer or permanent harm, such as breast implants and mesh. Since registries are often created by medical societies, registries are often directly or indirectly funded by industry. It is therefore essential that FDA have full access to conduct its own research on de-identified registry data, and to share that information with CMS to ensure appropriate coverage by Medicare and Medicaid.
Post-market user fees should also support a chemical post-market surveillance program, since exposure to these chemicals can cause chronic respiratory diseases, cardiovascular diseases, cancer, death, organ damage, and more. Although the FDA requires companies to perform chemical testing on their devices as part of their pre-market submissions, the FDA lacks the authority to reject submissions for data integrity issues involving chemical testing, and device manufacturers often make changes to materials and suppliers after the device is cleared or approved without alerting the FDA. We recommend establishing an FDA-administered post-market surveillance program for certain types of medical devices, such as devices that are inserted into or implanted in the patient, as well as devices that contain a breathing gas pathway. The latter are devices that the patient breathes through or from, such as ventilators, anesthesia equipment, breathing tubes, oxygen concentrators, CPAP and BiPAP machines, nebulizers, and incubators.
Once the FDA has granted permission to market a device, it is extremely difficult if not impossible for the FDA to rescind that permission, whether it is a 510(k) or PMA. The FDA staff who review submissions often err on the side of granting marketing authorization to the companies, reasoning that any safety and effectiveness issues that they might have missed will be discovered and addressed at the post-market stage. However, the staffing shortages and the largely voluntary nature of compliance make it likely that ineffective or unsafe devices will stay on the market for years, as was shown when FDA found that the Meridia device intended to prevent preterm births was ineffective and unsafe. In many cases, unsafe devices are only taken off the market when companies voluntarily do so because the products are no
longer financially beneficial. That could be because of lawsuits and/or because medical professionals or patients avoid them due to negative media coverage. It would be better for patients, health professionals, and our healthcare system if user fees helped increase the number of FDA staff and resources available for post-market surveillance and activities.
The above recommendations would improve MDUFA VI in ways that would greatly benefit patients and consumers and would also greatly benefit the reputable device companies that have the best quality control systems. Those companies are currently competing against companies that may charge less for their devices because they are not paying to have their devices tested by reputable testing labs or implementing quality systems. When the FDA can’t identify quality problems before a product goes to market, patients are harmed. The longer it takes to identify problems post-market, the more patients will be harmed. It is not possible to improve the health of all Americans without improving the resources available to ensure the safety and effectiveness of medical devices that so many Americans rely on.
In conclusion, there are ways to make the review of medical devices more efficient without shortchanging the quality of those reviews, and ways to increase and distribute user fee funding in ways that improve the quality of devices without harming device companies that are making quality products. We welcome the opportunity to work with the FDA, device manufacturers, and other stakeholders to improve MDUFA. We can be reached at info@center4research.org.
References:
[1] Zuckerman D.M., Brown P. & Das A. (2014) Lack of Publicly Available Scientific Evidence on the Safety and
Effectiveness of Implanted Medical Devices, JAMA Internal Medicine, 174(11): 1781-1787.
[2] Zuckerman D.M. and Brown P. (2015) Sufficiency of Information in 510(k) Summaries-Reply. JAMA
Internal Medicine, 175(5):864.
[3] Fox-Rawlings S,. Gottschalk L.B., Doamekpor L., Zuckerman D.M. (2018) Diversity in Medical Device Clinical
Trials: Do We Know What Works for Which Patients? Milbank Quarterly, 96 (3); 499-529.
[4] https://www.fda.gov/medical-devices/industry-medical-devices/notifications-data-integrity-medical-devices