July 5, 2022
National Center for Health Research’s Public Comment on FDA’s Draft Guidance on Fostering Medical Device Improvement
We are writing to express our views on “Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program.”
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research, policies, and programs on a range of issues related to health and safety. Our research and policy analyses of medical device issues is frequently quoted in medical journals, policy journals, and national and international media. We do not accept funding from companies that make products that are the subject of our work.
Although CDRH seems to be asking for feedback from industry, this plan will affect patients, consumers, and public health — and yet, this is the first opportunity our nonprofit organization has had to comment. As you know, MDIC dues are so high that few nonprofits that do not receive funding from industry are able to participate, and industry voices clearly control the agenda. It is therefore not surprising that this proposed draft guidance on Fostering Medical Device Improvement aligns so closely with the needs of medical device companies, but not with the needs of patients and consumers. We have many concerns about the proposed program, but here are 3:
- FDA staff are vetted to reduce conflicts of interest, but third-party appraisers have an inherent conflict of interest. If an entity wants to stay in business providing third party reviews, inspections, or appraisals that identify the firm’s strengths and weaknesses, they need to please customers — which in this case means pleasing the companies that they are appraising. That is an inherent conflict of interest that is in direct conflict with the integrity of the improvement program.
- The program seems to give qualifying manufacturers the option of revising their manufacturing practices and the information about their practices that they are required to submit to the FDA. Since qualifying for special treatment by the FDA would be based on the judgment of the 3rd party appraisers, that is not in the best interest of patients, consumers, or public health.
- We know from problems with device recalls (such as the recent Philips CPAC and ventilator recalls) and other voluntary programs that voluntary FDA programs are often inadequate to meet the needs of patients and consumers who rely on medical devices. We understand that industry prefers voluntary programs, but if a program is worth doing, it should not be voluntary because that will result in biased results, lack of enforcement, and as stated in the draft guidance, a lack of penalties for providing inaccurate information, failure to cooperate, and other activities that waste FDA resources and undermine the program. Moreover, it is likely that the companies that most need to improve the safety and quality of their products would be least likely to participate. That is not in the best interest of patients, consumers, or public health.
Millions of Americans rely on the safety and effectiveness of medical devices. Their lives and health depend on those devices. The proposed program is one of several recent proposals and programs that reduces the burden on industry and FDA staff by lowering the standards for medical devices. Moreover, it sets a dangerous precedent of outsourcing “appraisers” to make judgments about which companies are eligible for special treatment. Unlike 3rd party appraisers, FDA staff would be unbiased and knowledgeable, with an understanding of FDA’s mission as a public health agency.
The National Center for Health Research can be reached at info@center4research.org or at (202) 223-4000.