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COVID-19 Emergency Use Authorizations (EUA) for Medical Devices and Diagnostics

EUA being granted as there is significant potential for public health emergency that can affect national security or the health and security 

  1. Personal Protective equipment
  2. Diagnostic tests

Personal Protective Equipment

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  • Disposable filtering facepiece respirators (FFRs) approved by the National Institute for Occupational Safety and Health (NIOSH)
  • 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

Diagnostic Tests

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  • Qualitative Real-Time RT-PCR test for qualitative detection of nucleic acid from SARS-CoV-2 in upper and lower respiratory specimens from individuals suspected of COVID-19 by their healthcare provider
  • Positive test result  indicates RNA detected, patient is infected and presumed to be contagious; patient management should follow current CDC guidelines
  • Negative test result means RNA was not present in specimen; does not rule out COVID-19 and should not be used as the sole basis for treatment or patient management decisions

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Policy for Diagnostic Tests for COVID-19 during the Public Health Emergency 

Two policies for accelerating the development of certain laboratory tests for COVID-19

  1. EUA submission to FDA
  2. No EUA submission
    • When test is developed under State authorities and State takes responsibility for testing by laboratories
    • CLIA certified and meet requirements

Laboratories offering testing under Policy

  • AdventHealth
  • ARUP Laboratories
  • Assurance Scientific
  • Baylor Scott and White Medical Center – Temple
  • BioReference Laboratories
  • The Children’s Hospital of Philadelphia
  • Diatherix Eurofins
  • Emory Medical Laboratory, Emory Healthcare
  • Gravity Diagnostics
  • Henry Ford Health System
  • HMH Hackensack University Medical Center
  • Hospital of the University of Pennsylvania
  • Houston Methodist Hospital
  • Integrity Laboratories
  • Johns Hopkins Medical Microbiology Laboratory at Johns Hopkins Hospital
  • Montefiore Medical Center
  • New York Presbyterian Hospital -Weill Cornell Medicine (NYPH-WCM)
  • Next Bio-Research Services LLC
  • NYU Langone Medical Center
  • Quest Diagnostics Infectious Disease, Inc.
  • Stanford Health Care Clinical Laboratory
  • Texas Children’s Hospital Department of Pathology
  • TGen North, Clinical Laboratory
  • UCSF-Health
  • University of Washington
  • Viracor Eurofins Clinical Diagnostics

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N95 Respirators and Surgical Masks (Face Masks)

FDA regulates surgical masks and surgical N95 respirators differently based on their intended use

  • Surgical mask : Loose-fitting, disposable device that creates physical barrier between mouth and nose of wearer and potential contaminants in the immediate environment. Edges of mask are not designed to form seal around nose and mouth
  • N95 respirator: Respiratory protective device designed to achieve very close facial fit and very efficient filtration of airborne particles; edges designed to form seal around the nose and mouth.

N95 Respirators not for public use 

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Image credit: FDA, CDC