Enforcement policy for non-invasive remote monitoring devices used to support patient monitoring during the coronavirus disease 2019 (COVID-19) public health emergency (revised): guidance for industry and Food and Drug Administration staff
United States. Department of Health and Human Services. issuing body.
United States. Food and Drug Administration. issuing body.
Center for Drug Evaluation and Research (U.S.), issuing body.
Office of Product Evaluation and Quality (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Drug Evaluation and Research, October 2020
FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is committed to providing timely guidance to support response efforts to this pandemic. FDA is issuing this guidance to provide a policy to help expand the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and healthcare provider contact and exposure to COVID-19 for the duration of the COVID-19 public health emergency. This policy is intended to remain in effect only for the duration of the public health emergencyrelated to COVID-19 declared by the Secretary of Health and Human Services (HHS) on January 31,2020, effective January 27, 2020, including any renewals made by the HHS Secretary in accordancewith section 319(a)(2) of the Public Health Service (PHS) Act (42 U.S.C. 247d(a)(2)).
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
