National Center for Health Research, November 18, 2019
National Center for Health Research’s Public Comments on
Safer Technologies Program for Medical Devices; Draft Guidance for
Industry and Food and Drug Administration Staff; Availability
[FDA-2019-D-4048]
Thank you for the opportunity to express our views on the proposed Safer Technologies Program (STeP) for medical devices.
The National Center for Health Research (NCHR) is a non-profit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
We appreciate FDA’s efforts to get medical devices with an improved safety profile to consumers and patients more quickly. However, the mission of the FDA is to protect patients and consumers from medical products that are not proven safe or not proven effective. FDA guidance must be very clear how this program would protect patients from unsafe or ineffective medical devices. The proposed guidance is so vaguely worded that it is not possible to have confidence that patients’ needs will be protected.
We agree that increased interactions with FDA throughout the development process and more timely interactions could 1) speed development and review, and 2) improve the quality of the data available for review by providing more consideration into needed data, study design, and early detection of concerns. Unfortunately, most medical devices are cleared through review pathways that require little or no clinical data to demonstrate safety or effectiveness, and while premarket approval applications (PMA) require clinical trial data, those studies are often small, poorly designed, and lacking in appropriate control groups. Thus, while the proposed Safer Technologies Program may get medical devices to patients sooner, the program will be harmful to patients unless it also strengthens the premarket requirements for scientific evidence of safety and effectiveness.
Textured breast implants, Essure, POP mesh, and metal-on-metal hip replacements are just a few of the many examples of devices that were implanted in tens of thousands of patients and consumers prior to being removed from the market due to serious, unexpected complications. It is disturbing that the proposed guidance includes no explicit instructions aimed at reducing the harm caused when patients unwittingly serve as guinea pigs for implants and other devices that were not adequately tested prior to going on the market. It is not fair to patients or their physicians to rely primarily on post-market studies and surveillance, because too many patients will be harmed before those studies are completed, and too many of those studies will never be completed. We therefore respectfully urge the FDA to revise the proposed guidance in ways that ensure that all medical devices undergo more rigorous testing prior to being approved or cleared.
For questions or more information, please contact the National Center for Health Research at info@center4research.org or at (202) 223-4000.