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

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