Jeffrey Shuren
Director
Center for Devices and Radiological Health
Food and Drug Administration
Silver Spring, MD 20993
Dear Dr. Shuren,
As a follow-up to our phone call yesterday, we are writing to reiterate some of our major points. As members of the Patient, Consumer, and Public Health Coalition, we want to emphasize that we appreciate the wonderful life-saving benefits of many medical devices, even while we express concern that improvements to the 510(k) process are needed to reduce the number of patients whose lives are put at risk by medical devices whose risks outweigh the benefits for them.
You have received previous comments, letters, and testimony from us on the issues discussed in the working group report. Our main message is that safety must come first, and improvements are needed to the 510(k) process to better ensure the safety of medical devices. As a public health agency, FDA must balance various goals, but the #1 goal of safe medical products is more important than speed of approval; consistency with past CDRH policies, processes, or decisions; innovation; or jobs. Lives are at stake and too many people’s lives have been harmed by 510(k) devices. We strongly believe that improving the standards needed to prove safety and effectiveness of medical devices will ensure that U.S. companies flourish and create jobs at the same time as they contribute to public health.
Regarding the report, we support most of the working group’s recommendations. We want to emphasize our support of the following:
- Public health will be improved if FDA requires clinical trials for high risk devices. FDA needs to rethink its risk categories for medical devices, and should determine the risk level of a device based on what happens if it fails, as well as what happens if it works. In other words, if an elective device can kill or seriously harm you if it fails, that’s a high-risk device.
- FDA needs clear and expanded authority to conduct pre-market and post-market inspections of 510(k) devices.
- FDA needs clear and expanded authority to require post-market studies of 510(k) devices.
- FDA needs to make better use of its rescission authority for 510(k) devices, and improve or expand that authority if necessary.
- FDA needs a more stringent definition of “substantially equivalent” and needs to tighten the loopholes that are a result of multiple and split predicates. FDA also needs to more consistently review and remove products that were cleared on the basis of predicates that were subsequently found to be ineffective or unsafe.
- Creating a new category of a Class IIb device would be acceptable to us if it adds safeguards to appropriately categorized Class II devices, but not if it is used to move what should be a Class III device into the 510(k) review rather than a PMA.
- We believe that the third party review system has inherent conflicts of interest and is not cost effective. The process needs to be improved, and it should be used rarely. One improvement would be for FDA to assign the third party reviewer to the companies from the FDA’s list of certified reviewers, rather than have the companies select the reviewer from the FDA’s list. The assignment should take into account the expertise of the reviewers but otherwise be random, to ensure a fair system and level playing field.
Thank you again for taking the time to talk to us yesterday.
American Medical Women’s Association
Annie Appleseed Project
Breast Cancer Action
Center for Medical Consumers
Community Access National Network
Consumers Union
Government Accountability Project
Jacobs Institute of Women’s Health
National Consumers League
National Research Center for Women & Families / Cancer Prevention and Treatment Fund
National Women’s Health Network
Our Bodies Ourselves
THE TMJ Association
Union of Concerned Scientists
US Public Interest Research Group
WomenHeart
WoodyMatters