February 22, 2022
The Honorable Robert Califf, MD
Food and Drug Administration
Associate Commissioner for Policy
Center for Devices and Radiological Health
Food and Drug Administration
Dear Dr. Califf and Ms. Roth,
Our nonprofit consumer and public health organizations are key stakeholders that have been actively engaged in the Medical Device User Fee Act (MDUFA) meetings that are open to nonprofit stakeholders. We write to you today regarding the ongoing negotiations between the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) and the medical device industry to reauthorize MDUFA. As key stakeholders, we strongly urge the FDA to hold firm in the demands to strengthen pre- and post-market safety performance measures and surveillance as part of the MDUFA Commitment Letter as you enter into final negotiations with industry. MDUFA performance goals should include metrics regarding safety, and not just speed of review, in order to achieve the FDA’s mission to protect patients from unsafe products and enhance public health.
We are aware that prior MDUFA Commitment Letters have failed to include performance goals specific to patient safety, either pre-market or post-market. That is unacceptable. Unfortunately, there has also been a lack of transparency regarding the FDA’s negotiations with industry and regarding how user fees are dedicated to improving patient safety.
The vast majority of regulated medical devices continue to be approved through the 510(k) pathway, which according to FDA summaries rarely require evidence of safety or effectiveness.1 While the highest risk devices are required to submit clinical data, these are rarely randomized trials, often lack appropriate comparison groups, and are almost never blinded. When postmarket studies are mandated, they are often delayed and, in many cases, never implemented or completed as “required” by the FDA. User fees should therefore be increased to ensure that FDA has the resources needed to improve oversight of post-market studies and other surveillance.
Below are our recommendations as you continue negotiations with the medical device industry to finalize the MDUFA V Commitment Letter:
- User fee funds should be used to strengthen post-market surveillance activities, including timely monitoring of post-market clinical trials.
- User fees should strengthen adverse event monitoring systems and improve the implementation of device recalls.
- Performance goals should include safety-related metrics, such as data on the number of applications rejected and the number of re-submissions, rather than simply focusing on the number of applications approved, to provide a better overall picture of CDRH performance.
- User fees should help support and strengthen the timeliness and quality of facility inspections to reduce contamination of devices and ensure safe manufacturing processes.
We appreciate your efforts to strengthen the MDUFA program and protect patients and consumers during the current reauthorization cycle. Please contact Dr. Diana Zuckerman (email@example.com) at the National Center for Health Research with any questions.
Breast Implant Safety Alliance
Medical Device Problems
National Center for Health Research
Patient, Consumer, and Public Health Coalition
Patient Safety Action Network
USA Patient Network
- Zuckerman, D. M., Brown, P., & Nissen, S. E. (2011). Medical device recalls and the FDA approval process. Archives of internal medicine, 171(11), 1006-1011.