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
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Guidance for industry
- Contributor(s):
- 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.
- Publication:
- [Silver Spring, MD] : Center for Devices and Radiological Health, Office of Product Evaluation and Quality 2020
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Remote Consultation Telemedicine -- instrumentation Tonometry, Ocular -- instrumentation Vision Tests -- instrumentation Wireless Technology -- instrumentation COVID-19 United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- 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.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (8 pages)).
- NLM Unique ID:
- 9918227370106676 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/9918227370106676