August 4th, 2025
I’m Dr. Diana Zuckerman, president of the National Center for Health Research, a patient-centered, evidence-based public health think tank. Our Center is very involved in FDA issues pertaining to the safety and effectiveness of medical products, and I appreciate the opportunity to share my views today. My perspective is as a scientist trained in epidemiology and public health, and also as a patient with three implants in my body.
MDUFA performance measures have focused on speed, but they should also evaluate whether patients are protected from ineffective or unsafe products. All FDA user fees have performance goals that emphasize speedy reviews and FDA staff being available for meetings with companies to help them understand what they need to do to obtain approval or clearance. That makes sense –industry is paying for something that they want.
However, PDUFA uses a much greater percentage of its user fees for post- market surveillance and safety analysis, compared to MDUFA. All user fee negotiations are behind closed doors and patient, consumers, and health professionals are not allowed to be there or even to observe. We should be part of the process. Instead, we’ve been told that in past MDUFA negotiations, CDRH asked that user fees help support these kinds of safety and quality issues but that industry refused. Equally discouraging, CDRH complied with industry’s refusal.
The MDUFA V Commitment letter shows what happens when patients, consumers, and health professionals are excluded. The letter sounds like parents telling their children what they need to do to earn their allowance. Statements starting with “FDA will do x or “FDA’s response letter will include y” 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. This raises the question: Is Industry being regulated by FDA or do MDUFA agreements reverse that balance?
Why are performance goals all about what FDA has to do? Performance goals
should also be based on the types of accomplishments most important to patients, pre- and post-market.
Before FDA determines if a product can go on the market, CDRH lead reviewers are supposed to be like project managers who can rely on subject matter experts. But there aren’t enough subject matter experts. So, lead reviewers have to review the software, cybersecurity, electrical safety, biocompatibility etc. even if they don’t have that expertise. So, to meet their deadlines and keep their managers happy, many reviewers will assume criteria are met that they were not able to evaluate.
Those inferior reviews are common when a Commitment letter focuses on speed
of review, with no metrics for quality.
Let’s compare MDUFA commitments to user fees for other federal agencies, using the same analogy Congress used when it first passed FDA user fees. When we visit a National Park such as the Grand Canyon, we pay user fees (called entrance fees) to get in and those fees help pay for staff that keep the parks running. That’s in addition to the appropriations that all taxpayers pay. But those of us paying for admission don’t get to boss the Park Service
employees around. We don’t tell them what to do. We pay extra fees for food and lodging – shouldn’t the device industry pay extra for necessary inspections and post-market activities that help to make CDRH effective?
Bottom line: Entrance fees help ensure that parks function well, and MDUFA should help make sure CDRH functions well – by helping improve the quality of FDA reviews and the outcome for patients using devices.
Thanks to an analysis by Device Events, a company founded by a former FDA staffer, I can tell you that the number of adverse events more than tripled from 65,000 per month in 2015 to 225,000 per month this year (equivalent to 2.7 million/yr). Was that because of MDUFA pressure for speedy reviews? Some of these adverse events are very serious. In fact, this year so far, there have been 6,754 death reports to the FDA for medical devices. Let me give one example of a very common medical device, dental implants. There are 2.9 million adverse event reports for dental implants in MAUDE, and another 2.1 million that were included in summary reports, for a total of 5 million adverse event reports. But FDA has not held a public meeting for dental implants, nor has FDA provided public information about what those adverse events are or whether some types of dental implants may be safer or more effective than others. Everyone should have access to that information, and FDA should consider those specifics when it reviews new dental implants as well as those already on the market.
Since fewer than 5% of devices that FDA regulates provide clinical trials of safety or effectiveness before going on the market, it is essential that user fees should help pay for timely post-market reviews. That is especially important when FDA is being forced to speed up reviews and when staffing cuts have made reviews less thorough than they should be, and in-person inspections less frequent.
What kind of performance goals make sense for MDUFA?
CDRH lacks sufficient staff to review DTC ads, detailing activities, or ads to
doctors that directly or indirectly promote inappropriate off label use. User fees
should help pay for those activities.
User fees should also support FDA staff to create Patient Booklets, Informed Consent Checklists, and other materials that CDRH has used to help ensure that patients can make informed decisions. This is especially important when the device labels are intended for doctors, not for patients. User fees should also support Dear Doctor” letters, warnings to patients, and recall campaigns. PMA reviews should be rated on whether clinical studies are too small or too short-term. Safety and effectiveness data should be analyzed for male and female patients of different ages. Performance goals should also specify how many approvals were based on at least one randomized, controlled trial demonstrating robust evidence of a favorable benefit-risk profile. Post-market surveillance should sometimes result in FDA warnings, recalls, or withdrawals. Performance data should specify how often the FDA uses these mechanisms and the reasons for those actions.
What about the money?
MDUFA user fees are a fraction of PDUFA user fees, even for the largest device companies. The 510k user fees are too small to pay for a thorough speedy review, so either the review times need to be longer or the fees need to be greater. Given the cuts in FDA staffing this year, and the importance of speedy reviews to industry, it’s inevitable that improving quality requires increasing the fees. If those increases are adequate, it will still be possible for the FDA to waive fees for the smallest device companies, as they’ve done in the past.
A final word: User fees should be based on the average cost of each review. Past commitment letters have said the fees will be reduced if the number of applications exceeds expectations. That makes no sense at all – each review requires time and attention. FDA should reject industry demands that fees be reduced if more applications are received.