May 17, 2021
National Center for Health Research’s Public Comments to FDA on Class I Surgeon’s and Patient Examination Gloves
We are writing to express our views on the U.S. Food and Drug Administration’s (FDA) notice regarding Class I surgeon’s and patient examination gloves.
The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.
NCHR was very concerned about the January 2021 last-minute effort by the Trump Administration to no longer require a report under section 510(k) of the FD&C Act for Class I surgeon’s and patient examination gloves. This move was done without consulting the FDA, clearly ignored scientific expertise, and put millions of patients at risk. Moreover, this decision appeared to take advantage of the COVID-19 public health emergency by attempting to make pandemic-related changes permanent, and by not allowing adequate time for input from the public and other stakeholders.
The deregulatory efforts of January 2021 were similar to policies enacted in April 2020, when dangerous shortages of PPE led FDA to — at least temporarily — deregulate several PPE such as face masks, surgical masks and respirators through the use of Emergency Use Authorizations (EUAs), replacing the usual requirements to provide scientific evidence before marketing these products.1,2 Deregulating medical products intended to prevent potentially fatal infections poses unacceptable risks for patients.
We therefore enthusiastically support the proposal to withdraw the January exemption for the Class 1 gloves noted above, returning the requirement for a report under section 510(k) of the FD&C Act.
References
- Zuckerman DM. Emergency Use Authorizations (EUAs) Versus FDA Approval: Implications for COVID-19 and Public Health. American Journal of Public Health. 2021; 111(6): 1065-1069.
- US Food and Drug Administration. Enforcement policy for face masks and respirators during the coronavirus disease (COVID-19) public health emergency (revised): guidance for industry and Food and Drug Administration staff. May 2020. Available at: https://www.fda.gov/media/136449/download.