Enforcement policy for face shields, surgical masks, and respirators during the coronavirus disease (COVID-19) public health emergency: guidance for industry and Food and Drug Administration staff

Enforcement policy for face shields, surgical masks, and respirators during the coronavirus disease (COVID-19) public health emergency: 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, March 13, 2023
Language(s):
English
Format:
Text
Subject(s):
COVID-19 -- prevention & control
Government Regulation
Masks -- standards
Medical Device Legislation
N95 Respirators -- standards
Personal Protective Equipment
Respiratory Protective Devices -- standards
United States
United States. Food and Drug Administration
Genre(s):
Guideline
Technical Report
Abstract:
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. This policy is intended to remain in effect for 180 days following expiration of the COVID-19 public health emergency declaration under section 319 of the Public Health Service Act (42 U.S.C. 247d(a)(2)), unless a different intended duration is set forth in a finalized version of the FDA guidance, “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency,” available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/transition-plan-medicaldevices-fall-within-enforcement-policies-issued-during-coronavirus-disease. For further information, please refer to the Federal Register notice titled “Guidance Documents Related to Coronavirus Disease 2019 (COVID-19).” Given this public health emergency, and as discussed in the Notice in the Federal Register of March 25, 2020, titled “Process for Making Available Guidance Documents Related to Coronavirus Disease 2019,” available at https://www.govinfo.gov/content/pkg/FR-2020-03-25/pdf/2020-06222.pdf, this guidance was implemented without prior public comment because FDA had determined that prior public participation for this guidance was not feasible or appropriate (see section 701(h)(1)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR 10.115(g)(2)). This guidance document was implemented immediately, but it remains subject to comment in accordance with the Agency’s good guidance practices. For the current edition of the FDA-recognized consensus standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
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:
9918662286806676 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/9918662286806676