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EUA: emergency use authorization

FDA

The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies. 

Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

Section 564 of the FD&C Act was amended by the Project Bioshield Act of 2004 and was further amended by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA), the 21st Century Cures Act of 2016, and Public Law 115-92 of 2017.

SOURCE: FDA

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COVID-19 Emergency Use Authorizations (EUA)

COVID-19 EUA
NIAID: novel coronavirus SARS-CoV-2

Resource

On 4 Feb 2020, the Secretary of the Department of Health and Human Services (HHS) determined that there is a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad and that involves a novel (new) coronavirus now named SARS-CoV-2, which causes the illness COVID-19.

Personal protective equipment

On the basis of this determination, the Secretary declared that circumstances exist justifying the authorization of emergency use (EUA) of personal respiratory protective devices during the COVID-19 outbreak, pursuant to section 564 of the FD&C Act, subject to the terms of any authorization issued under that section.

If you have questions, please email CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov.

NIOSH-approved disposable filtering facepiece respirators (FFR)

On 02 Mar 2020, the FDA issued an EUA for emergency use of, (1) all disposable filtering facepiece respirators (FFRs) approved by the National Institute for Occupational Safety and Health (NIOSH), in accordance with 42 CFR Part 84, as non-powered air-purifying particulate FFRs, and (2) FFRs that were NIOSH-approved but have since passed the manufacturers’ recommended shelf-life, for use in healthcare settings by healthcare personnel (HCP) to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages .

In vitro diagnostics EUA

On 29 Feb 2020, the FDA issued an immediately in effect guidance with policy specific to this public health emergency. CDC has granted a right of reference to the performance data (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device.

The templates for these EUA submissions are available:

If you need additional information, please refer to the FAQs on Diagnostic Testing for SARS-CoV-2.

TaqPath COVID-19 Combo Kit

On 13 Mar 2020, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use the Thermo Fisher Scientific, Inc. TaqPath COVID-19 Combo Kit for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider.

cobas SARS-CoV-2

On 12 Mar 2020, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use the Roche Molecular Systems, Inc.(RMS) cobas SARS-CoV-2 test for use on the cobas 6800/8800 Systems for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria.

New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR

On 29 Feb 2020, the FDA issued an EUA to authorize the emergency use of Wadsworth Center, New York State Department of Public Health’s (CDC) New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel for the presumptive qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal/oropharyngeal swabs and sputa collected from individuals who meet CDC COVID-19 clinical and/or epidemiological criteria.

CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel

On 04 Feb 2020, the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Centers for Disease Control and Prevention’s (CDC) 2019-Novel Coronavirus (2019-nCoV) Real-Time Reverse Transcriptase (RT)-PCR Diagnostic Panel for the presumptive qualitative detection of nucleic acid from the 2019-nCoV in upper and lower respiratory specimens.

MORE INFO: FDA

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FAQs on diagnostic testing for SARS-CoV-2

Resource

Throughout this page and the Policy for Diagnostics Testing for Coronavirus Disease-2019, references to laboratories that are “certified to perform high complexity testing under CLIA” are referring to CLIA certified laboratories that meet the regulatory requirements to perform high-complexity testing.

Which laboratories are offering testing under the Policy for Diagnostics Testing for COVID-19?

Many commercial and healthcare system/academic laboratories have notified the FDA that they have validated their own COVID-19 test and have started patient testing as set forth in the FDA’s Policy for Diagnostics Testing for Coronavirus Disease-2019. The laboratories listed below have agreed to be identified on the FDA’s website.

  • AdventHealth
  • ARUP Laboratories
  • Baylor Scott and White Medical Center – Temple
  • BioReference Laboratories
  • The Children’s Hospital of Philadelphia
  • HMH Hackensack University Medical Center
  • Hospital of the University of Pennsylvania
  • Johns Hopkins Medical Microbiology Laboratory at Johns Hopkins Hospital
  • Laboratory Corporation of America (LabCorp)
  • Montefiore Medical Center
  • New York Presbyterian Hospital -Weill Cornell Medicine (NYPH-WCM)
  • NYU Langone Medical Center
  • Quest Diagnostics Infectious Disease, Inc.
  • Stanford Health Care Clinical Laboratory
  • Texas Children’s Hospital Department of Pathology
  • UCSF-Health
  • University of Washington
  • Viracor Eurofins Clinical Diagnostics

Note that many other laboratories, including public health, commercial, and healthcare system/academic laboratories, around the country are providing testing for COVID-19 using an Emergency Use Authorization (EUA) authorized test

Are two or more viral targets needed to validate an RT-PCR SARS-CoV-2 assay?

Based on evidence that has become recently available, and with the increased spread of COVID-19, FDA believes an appropriately validated single viral target SARS-CoV-2 assay could provide acceptable performance.

I am developing a test with a protocol, primers, and probes identical to the CDC’s EUA authorized test. Do I need to start from scratch with my validation or can I validate my test with a bridging study to the CDC’s test?

The CDC has granted a right of reference to the performance data contained in the CDC’s EUA request (FDA submission number EUA200001) to any entity seeking an FDA EUA for a COVID-19 diagnostic device. The FDA is available to work with you on your bridging study and will soon publish a template on FDA.gov.

I am developing a SARS-CoV-2 test kit and want to pursue an EUA. Do I need to have all of my validation and documentation completed and submitted in an EUA request to FDA before engaging with the FDA?

No. The FDA is interested in early interactions with test developers and will review data on a rolling basis. We encourage you to reach out to us at CDRH-EUA-Templates@fda.hhs.gov to begin pre-EUA discussions, even if you do not have your validation and/or documentation completed.

MORE QUESTIONS: FDA

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Policy for COVID-19 diagnostics testing in CLIA-certified laboratories

FDA

The Food and Drug Administration (FDA or Agency) is issuing this guidance to provide a policy for novel coronavirus (COVID-19) molecular diagnostics tests developed and used in laboratories certified to perform high-complexity testing under the Clinical Laboratory Improvement Amendments (CLIA) prior to issuance of emergency use authorizations (EUA) for such tests.

On 4 Feb 2020, the Secretary of Health and Human Services 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). 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 an accelerated policy enabling laboratories to use tests they develop faster in order to achieve more rapid 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& 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.

SOURCE: FDA

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