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Full article title Policy for diagnostic tests for Coronavirus Disease-2019 during the public health emergency
Author(s) U.S. Food and Drug Administration
Author affiliation(s) U.S. Food and Drug Administration
Primary contact Email: CDRH-Guidance at fda dot hhs dot gov
Year published 2020
Volume and issue FDA-2020-D-0987
Page(s) 1–11
Distribution license Public domain
Website https://www.fda.gov/regulatory-information/...
Download https://www.fda.gov/media/135659/download (PDF)

Preface

Public comment

You may submit electronic comments and suggestions at any time for Agency consideration to https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. Identify all comments with the docket number FDA-2020-D-0987. Comments may not be acted upon by the Agency until the document is next revised or updated.

Additional copies

Additional copies are available from the internet. You may also send an e-mail request to CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance. Please include the document number 20010 and complete title of the guidance in the request.

Disclaimer

This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page.

I. Introduction

The Food and Drug Administration (FDA or Agency) is issuing this guidance to provide a policy to help accelerate the availability of novel coronavirus (COVID-19) diagnostic tests developed by laboratories and commercial manufacturers during the public health emergency.

On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus (2019-nCoV).[1] Rapid detection of COVID-19 cases in the United States requires wide availability of diagnostic testing to control the emergence of this rapidly spreading, severe illness. This guidance describes a policy for laboratories and commercial manufacturers to help accelerate the use of tests they develop in order to achieve more rapid and widespread testing capacity in the United States.

In light of this public health emergency, this guidance is being implemented without prior public comment because the FDA has determined that prior public participation for this guidance is not feasible or appropriate (see section 701(h)(1)(C)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and 21 CFR 10.115(g)(2)). This guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency’s good guidance practices.

FDA’s guidance documents, including this guidance, 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 guidance means that something is suggested or recommended, but not required.

II. Background

There is currently an outbreak of respiratory disease caused by a novel coronavirus that was first detected in Wuhan City, Hubei Province, China, which has now been designated a pandemic by the World Health Organization (WHO) and which has been detected internationally, including cases in the United States. The virus has been named “SARS-CoV-2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). SARS-CoV-2 has demonstrated the capability to spread rapidly, leading to significant impacts on healthcare systems and causing societal disruption. The potential public health threat posed by COVID-19 is high, both globally and to the United States. To respond effectively to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. FDA believes the policy set forth in this guidance will help address these urgent public health concerns by helping to expand the number and variety of diagnostic tests, as well as available testing capabilities in reference and commercial laboratories and healthcare settings.

The Centers for Disease Control and Prevention (CDC) laboratories have supported the COVID-19 response, including development of a diagnostic assay that was issued an Emergency Use Authorization (EUA) on February 4, 2020.[a] Since authorizing CDC’s EUA, FDA has been actively working with other SARS-CoV-2 diagnostic test developers to help accelerate development programs and respond to requests for in vitro diagnostic EUAs. However, the severity and scope of the current COVID-19 situation around the globe necessitates greater testing capacity for the virus than is currently available.[b]


Footnotes

  1. See FDA’s February 4, 2020 letter authorizing CDC’s 2019-nCoV (RT)-PCR Diagnostic Panel for the presumptive qualitative detection of nucleic acid from the 2019-nCoV in upper and lower respiratory specimens, available at https://www.fda.gov/media/134919/download. This EUA was re-issued in its entirety on March 15, 2020 to reflect a number of amendments, including changes to the intended use and primer and probe materials.
  2. Nothing in this guidance is intended to impact or supersede CDC’s recommendations regarding which patients should be tested for COVID-19.

References

Notes

This presentation is faithful to the original, with some changes to presentation, grammar, and punctuation. In some cases important information was missing from the references, and that information was added. The original guidance was created by a U.S. federal employee, and therefor that document legally belongs in the public domain.