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Requisites for EUA qualification – Elexes
Elexes Medical Consulting

Why was EUA started?

The Emergency Use Authorization (EUA) program was first established in 2004 and has a well-defined process around it. 

What are the criteria for an EUA?

When the Secretary of the Department of Health and Human Services (HHS) justifies the existing emergency circumstance to authorities, only then the FDA can issue an EUA. Depending upon the following criteria, the HHS Secretary declares an emergency:

  • The Secretary of Homeland Security claims that a Chemical, Biological, Radiological, or Nuclear (CBRN) agent(s) attack is causing a domestic emergency or has the potential for it. 
  • The Secretary of Homeland Security claims that a CBRN agent(s) attack is causing a military emergency or has the potential for it.
  • The Secretary of Homeland Security claims that a CBRN agent(s), attack, an ailment or a condition, considered as being caused by such an agent, is responsible for a public health emergency, or has the potentiality to create the same, or can hamper national security or the health and security of the foreigners having U.S. citizenship
  • According to section 319F-2 of the Public Health Service (PHS) Act, the Secretary of Homeland Security identifies a threat from a material, which adequately creates a negative impact on national security or the health and security of the foreigners having U.S. citizenship

How has the EUA helped in the COVID 19 situation? 

Recently, on February 4th 2020, the secretary of HHS decided to pursue the EUA under the FD&C act to fight against the emergency due to the attack of novel coronavirus (nCoV), which affects public health as well as the health and security of  U.S citizens who live in foreign countries.

As a result, the New York SARS-CoV-2 Real-time Reverse Transcriptase (RT)-PCR Diagnostic Panel got the first EUA from the FDA as an IVD kit for the qualitative detection of COVID-19. 

So far EUA has been issued to 57 entities, amongst them

  • Three manufacturers have certification with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high, moderate complexity tests, and for patient care settings, operated under a CLIA Certificate of Waiver, Certificate of Compliance. 
  • Twelve manufacturers have certification with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high, and moderate complexity tests. 
  • Twenty-six manufacturers have certification with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high complexity tests. 

From the above 41 manufacturers, 37 manufacturers have developed molecular-based laboratory-developed tests (LDTs) kits, whereas 4 manufacturers develop serological test kits.

  • Sixteen laboratories got EUA authorization for high complexity molecular-based laboratory-developed tests; such as Infectious Diseases Diagnostics Laboratory (IDDL), Boston Children’s Hospital, etc. 

How many devices and of what kind have been approved by the FDA so far under EUA for COVID 19?

Total 16 devices approved so far under EUA. The clinical purpose of these devices are different. For example: 

Personal protective equipment: 5
Reprocessing medical devices: 4
Ventilator: 1
Extracorporeal Blood Purification Devices: 3 

Spectra Optia Apheresis System with the Depuro D2000 Adsorption Cartridge manufactured by Terumo BCT, Inc. and Marker Therapeutics AG; CytoSorb device manufactured by CytoSorbents, Inc., Seraph 100 Microbind Affinity Blood Filter device manufactured by ExThera Medical Corporation. 

Other Medical Devices: 3

Space and Outlook Pumps manufactured by B.Braun Medical, Inc; TransAeris Diaphragmatic Pacing Therapy System manufactured by Synapse Biomedical, Inc.; Diaphragm Pacing Therapy System manufactured by Lungpacer Medical, Inc.

How many more devices and of what kind are expected to apply for EUA in the coming days/months?

Many device manufacturers are planning to get in the mix and help; 230 test developers are working with the FDA and will submit EUA requests to FDA for the detection of the virus through laboratory tests. Additionally, many medical device companies are going to expand indications for existing devices for an application in COVID, or get an EUA for support devices like ventilators. 

Elexes is experienced in national and international regulatory submissions,  safe and effective marketing of healthcare technologies, and how to provide an assurance of marketing compliance. In the current COVID 19 pandemic situation, prompt action needs to be taken for accelerating technologies to control the spread, the right partner shall make a difference.

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