Recently, the QNR team published an article concerning the World Health Organization’s response to the Covid-19 pandemic. Given the size of the United States market, and given that it is the central office of our business and core services are located there, we feel it appropriate to provide a brief overview of the response in the US with some background, current status, and future outlook.
The US Food and Drug Administration (FDA) is a globally recognized and respected agency that regulates and oversees the basic functions related to tobacco and medical products, food and veterinary medicine, operations and global regulatory policies and operations. Due to the severity of the Covid pandemic situation, EUAs (Emergency Use Authorizations) were requested to facilitate the availability of reliable, but not fully approved, vaccines to prevent COVID as soon as possible.
EUAs are used in health emergencies, not only for vaccines, but also for any medical product not yet licensed, or for a use not yet approved for diagnosing, treating and preventing disease.
Background and Current Status
In February, 2020, The US Department of Health and Human Services (HHS), the agency that oversees the FDA, determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens, and declared that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19, personal respiratory protective devices, and other medical devices, including alternative products used as medical devices for use during the COVID-19 outbreak.
In the case of COVID-19 vaccines, manufacturers deciding to apply for an EUA have been required to meet certain regulatory requirements including those for Phase 1 and 2 testing of a vaccine, and if not the full Phase 3 at least a specified portion of them.
The first Emergency Use Authorization granted to a vaccine to fight Covid-19 was to Pfizer-BioNTech, and it was only one of many issued by the FDA during the pandemic.
Since the time of that first authorization, there have been many businesses that have received emergency authorization to place their devices on the US market, including many global medical device companies, pharmaceutical companies, and household names whose products we use every day. The scope of the EUAs include a broad range of intended uses impacting patients, both direct and indirect exposure, and proactive and reactive in nature. They cover diagnostic, non-diagnostic, and therapeutic medical devices as well as the vaccine.
The (Hopeful) Return to Normal: FDA’s EUA Transition and Future Outlook
Through the time of this writing, emergency use authorizations have continued to be active, covering multiple product categories. However, it appears that a transition period has begun as the COVID-19 issue matures.
As of late 2021, the FDA has begun clearing products to market using standard methods, including by 510(k) submission and clearance. On November 1, 2021, FDA cleared the first 510(k) for a COVID-19 test. The test, which has been offered under an EUA since March 2020, is the second SARS-CoV-2 diagnostic test granted marketing authorization that permits the test to be marketed beyond the public health emergency.
Looking to the future, with a standard clearance for certain categories of these devices now available as a predicate for standard FDA submissions, we may see a reduction and/or trailing off of emergency submissions and authorizations by companies with a longer term
vision and desire to move forward using established methods.
Only time will tell, and many throughout industry as well as the general population remain optimistic that conditions of the COVID-19 situation will improve to the point where emergency authorization is no longer necessary, the FDA decides to revoke the emergency use authorization as with past pandemics and/or emergencies, and manufacturers return to standard processes for commercial release of product to the US market.
Resources
US Food and Drug Administration (FDA): Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices
F.D.A. U.S. Food and Drug Administration.
La FDA toma acción clave en la lucha contra el COVID-19 al emitir una autorización de uso de emergencia para la primera vacuna contra el COVID-19
https://www.fda.gov/vaccines-blood-biologics/vaccines/explicacion-de-la-autorizacion-de-uso-de-emergencia-para-las-vacunas
Emergency Use Authorization for Vaccines Explained
https://www.fda.gov/vaccines-blood-biologics/vaccines/emergency-use-authorization-vaccines-explained
Emergency use authorization
https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization
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