Enforcement policy for clinical electronic thermometers: guidance for industry and Food and Drug Administration staff

Enforcement policy for clinical electronic thermometers: guidance for industry and Food and Drug Administration staff

Collection:
Health Policy and Services Research
Contributor(s):
Center for Devices and Radiological Health (U.S.), issuing body.
Publication:
[Silver Spring, MD] : Center for Devices and Radiological Health, November 3, 2023
Language(s):
English
Format:
Text
Subject(s):
Device Approval
Government Regulation
Guideline Adherence
Thermometers -- standards
United States
Genre(s):
Guideline
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 and public health emergencies (PHEs). Following the emergence of COVID-19, FDA first issued guidance in April 2020 to provide a policy to help expand the availability of clinical electronic thermometers to address the PHE. At the time, FDA stated that the policy described in the guidance was intended to remain in effect only for the duration of the PHE related to COVID-19 declared by the Secretary of Health and Human Services (HHS) in accordance with section 319 of the Public Health Service Act (PHS Act). On March 13, 2023, FDA announced in the Federal Register notice “Guidance Documents Related to Coronavirus Disease 2019 (COVID-19),” that the guidance document was being revised to continue in effect for 180 days after the expiration of the COVID-19 PHE declaration, and that, during that time, FDA would intend to further revise this guidance, among others. The policies described in this guidance take into account that the April 2020 version of the guidance is intended to remain in effect through November 7, 2023, unless superseded by a final guidance before that date.
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (9 pages))
NLM Unique ID:
9918733087106676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918733087106676