Comments of the National Research Center for Women & Families
Cancer Prevention and Treatment Fund
Medical Device User Fees (MDUFA)
[Docket no. FDA-2010-N-0389]
November 1, 2010
The National Research Center for Women & Families and its Cancer Prevention and Treatment Fund is writing in response to the Food and Drug Administration’s request for comments on the overall performance of the medical device user fee program, and how the program can be strengthened and improved.
Assessment of the overall performance of MDUFA
User Fees Are Too Low
A major concern is that the medical device user fees are too low to adequately support the Center for Devices and Radiological Health’s (CDRH) efforts to clear or approve safe and effective medical devices in a timely manner.
Although the PMA and NDA process are similar, the FDA charges much smaller user fees to review medical devices than it charges to review prescription drugs, even when the same companies make devices and pharmaceuticals. This exacerbates the lack of resources at CDRH. For example, in fiscal year 2010, the FDA charged a standard fee of only $4,007 for a 510(k) submission (half that amount for small companies) and $217,787 for an original PMA (one-quarter that amount for small companies), compared to user fees ranging from $702,750 to $1,405,500 for a New Drug Application (NDA). More important, the user fees for 510(k) reviews and for Premarket Approvals (PMAs) are a small fraction of the actual cost of the reviews and an even smaller fraction of what it would cost to do a more thorough review that includes post-market surveillance and a timely review of DTC advertising.
The inadequacy of the fees for the 510(k) is especially egregious. User fees of only a few thousand dollars do not provide the FDA the resources needed to assure the safety and effectiveness of medical devices reviewed through the 510(k) process. The largest companies should pay the entire cost of the 510(k) review, as well as a substantial additional user fee to review every new ad that the company directs to consumers. With the possible exception of the smallest companies, all device companies should be able to afford a 510(k) user fee of $10,000 or more.
Even the PMA user fees are disproportionately low compared to reviews for prescription drugs. The user fees for PMAs and NDAs should be comparable. Although we support sliding fee scales for smaller device companies, the fees must be adequate to provide a meaningful contribution of resources for the work involved.
Aspects of the program that should be retained, changed, or discontinued to strengthen and improve the program
The new MDUFA legislation should:
- Substantially increase the FDA resources for both 510(k) reviews and PMAs.
- Require higher standards of safety and effectiveness for devices that can potentially sustain life, save lives, or harm lives. They should be held to at least as high as standards for prescription drugs.
- Focus on safety and ensure that only safe predicate devices can be used for the 510(k) clearance process.
- Focus on post-market surveillance of all medical devices, inspections of all medical devices, and pre-reviews of direct to consumer advertising of medical devices.
- State clearly that user fees are not “payments for service.”
Substantially Increase Resources
MDUFA should protect the public health by improving the safety and efficacy of all medical products, whether PMA or 510(k). That requires higher user fees, performance standards that focus on the quality of the review and not just the speed, and reviews that provide patients, consumers, and healthcare providers with information about how well the product works compared to other similar products on the market.
Higher Standards for Safety & Effectiveness
FDA laws and regulations should require the same standards of safety and efficacy for devices as for drugs. A Class IIb category should not be added to the 510(k) process, unless it is a relatively small category for products that can not cause substantial harm if they fail. To protect the public, a much larger percentage of new devices should be reviewed under the PMA system. If a device can cause serious harm if it should fail- even if it is not life sustaining or life saving if it works-it should be reviewed by an improved version of the PMA process.
The National Research Center for Women & Families recently conducted a study of high-risk recalls of medical devices for the past 10 years, based on the FDA’s own data. The Center expected that most high risk recalls – those that the FDA deemed necessary to save lives and prevent serious harm – would be devices approved through the PMA process. After all, the PMA process is for high risk devices, whereas the 510(k) process is for low to moderate risk devices. However, the Center found that most of the high risk recalls involved devices that had been cleared through the 510(k) process. Many of these devices were responsible for patients dying from devices that did not work, although some were unsafe even when they did work. In addition, 7 percent had been exempt from 510(k) review, and therefore merely registered with the FDA. That should never happen, and indicates that the standard for exemption is too low.
If a device can kill you if it fails, or if it does not work accurately, then it should be considered a high-risk device, not just a high-risk recall. If it is a high-risk device, it should be Class III and submitted for a PMA review. To protect patients, high-risk devices should never go through the 510(k) process. That especially includes implants and diagnostic devices for serious diseases or those that emit radiation.
Focus on Safety Especially Concerning Predicate Devices
We agree with the recent CDRH 510(k) Working Group report regarding the need for a useable, searchable database of 510(k) predicates. Part of the MDUFA improvements should be the assurance that a device will not be cleared as “substantially equivalent” to a previously recalled device, or to a device that was cleared on the basis of a predicate device that was substantially equivalent to a recalled device.
Safety also needs to be measured by how a device functions in the real world. The recent New York Times article on deaths that result when IV tubes that are compatible with other tubes, perfectly displays a system that is not working. Even if the risks are caused by human error, that does not excuse the device or the FDA. It should be the FDA’s job to require that devices be easy enough to use that human error is rare, not a common problem.
Currently, more than 90% of new medical devices are not required to undergo clinical trials to prove that they are safe and effective. What is needed for moderate and high-risk devices are well-designed studies, not anecdotal clinical data. Clinical trials conducted on devices are often too small or too short-term to provide meaningful safety and effectiveness data. The FDA must demand better data to protect public health. At the same time, they should give priority to reviewing applications for breakthrough products and products that provide comparative effectiveness data that tells patients and providers how this new device compares to others already on the market.
According to a 2009 FDA report, “One of CDRH’s most important roles in carrying out its public health mission is to monitor and evaluate the safety and effectiveness of medical devices postmarket.” User fees should fund postmarket surveillance because the number and complexity of medical devices has increased and the number of medical devices that are imported (and subject to fewer inspections) has also significantly increased.
The current law needs to be changed to allow conditions of approval of 510(k) devices that include postmarket studies. It makes no sense that the process that requires the least scrutiny before approval allows no post-market requirements. This must be changed in the MDUFA reauthorization.
Postmarket studies and surveillance of PMA devices are also urgently needed. The clinical trials used as the basis for medical devices are almost always less well designed and executed than those for pharmaceuticals.
One of the ways to improve post-market surveillance is for the FDA to implement a system of unique identifiers for medical devices and patient registries, especially for implants. For example, hip replacement patients do not generally know which company made their hip implant, the model or any specific information about it. If hip joints are recalled, patients are left in the dark. In contrast, toasters, TVs, and DVRs all have unique identification numbers.
Postmarket surveillance will help to identify ineffective and unsafe devices. If a product is on the market and found to be ineffective or unsafe (such as ReGen mesh or medical tubes that are easily misconnected), it is the FDA’s responsibility to take the unsafe or ineffective devices off the market. ReGen mesh is a high-profile example, but there are many 510(k) medical devices that apparently do not work – not surprising, since clinical trials were not required. Vagus Nerve Stimulation, the NeuroStar TMS depression device, and laser treatments of lymphedema, are just a few of the many medical devices that have wasted millions of healthcare dollars. Bladder slings are an excellent example of products that often do more harm than good, and where the adverse reactions seriously harm patients and cost patients and the healthcare system tens of thousands of dollars per patient.
If user fees are high enough to substantially offset the cost of the reviews of new devices, then more appropriations would be available for post-market safety decisions, so that they can be made in a timely manner.
Inspections of the manufacturers of devices are crucial. Devices cleared by the 510(k) process should be subject to FDA inspections, and third party inspections are not adequate. The need for more resources for inspections of PMA devices is also urgent, as is the need for more inspections of foreign medical device plants. They should be inspected at least as often as domestic plants.
Pre-review of DTC Ads for Medical Products
As we mentioned earlier, medical device makers should pay substantial additional user fees for every new ad that the company directs at consumers. Advertisements are designed to persuade people to purchase something, which means they emphasize the benefits over the risks.
User Fees, Not Payment for Services
We will urge Congress to reconsider legislation like Rep. Maurice Hinchey’s HR 4816 that breaks the connection between user fees and specific performance levels. The FDA should not be restricted by performance timeframes that undermine public health performance standards.
PDUFA IV and FDAAA improved safeguards for pharmaceuticals, but not for devices. The reauthorization of MDUFA gives Congress and the FDA an opportunity to strengthen CDRH by increasing its resources, holding medical devices to higher safety and effectiveness standards, and ensuring that predicate devices cited for new devices are safe. MDUFA reauthorization should also provide funding for postmarket surveillance, inspections, pre-review of DTC ads, and it should clearly state that user fees are not payments for service.
National Research Center for Women & Families / Cancer Prevention and Treatment Fund
 Department of Health and Human Services, Food and Drug Administration, Federal Register Notice [Docket No. FDA-2009-N-0338]. Medical Device User Fee Rates for Fiscal Year 2010 (August 2009). U.S. Government Printing Office Web site: http://edocket.access.gpo.gov/2009/E9-18456.htm Accessed October 28, 2010.
 Department of Health and Human Services, Food and Drug Administration, Federal Register Notice [Docket No. FDA-2009-N-0339]. Prescription Drug User Fee Rates for Fiscal Year 2010 (August 2009). U.S. Government Printing Office Web site: http://edocket.access.gpo.gov/2009/E9-18457.htm Accessed June 18, 2010.
 U.S. Department of Health and Human Services, Food and Drug Administration, Division of Epidemiology Office of Surveillance and Biometrics Center for Devices and Radiological Health (November 2009). Report on Implementation of Post-Approval Studies for Medical Devices Workshop.