Enforcement policy for remote ophthalmic assessment and monitoring devices during the coronavirus disease 2019 (COVID-19) public health emergency : guidance for industry and Food and Drug Administration staff Guidance for industry United States. Department of Health and Human Services United States. Food and Drug Administration Remote Consultation Telemedicine -- instrumentation Tonometry, Ocular -- instrumentation Vision Tests -- instrumentation Wireless Technology -- instrumentation COVID-19 The Food and Drug Administration (FDA or the Agency) 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 capability of remote ophthalmic assessment and monitoring devices to facilitate patient care while reducing patient and healthcare provider contact and exposure to COVID-19 during this pandemic. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service (PHS) Act. [Silver Spring, MD] : Center for Devices and Radiological Health, Office of Product Evaluation and Quality 2020 United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Devices and Radiological Health (U.S.), issuing body. Technical Report Text 1 online resource (1 PDF file (8 pages)). nlm:nlmuid-9918227370106676-pdf 9918227370106676 http://resource.nlm.nih.gov/9918227370106676 English United States The National Library of Medicine believes this item to be in the public domain. https://creativecommons.org/publicdomain/mark/1.0