FDA EUA | FDA Emergency use Authorization for Medical Devices
Article Context:
“In case of an emergency, please dial 911.” That’s one kind of emergency, but not what we’ll address today. This emergency is in light of COVID-19. Simply, it’s the power of the FDA to grant Emergency Use Authorizations (EUAs). EUA authority permits FDA to authorize formally unapproved products for temporary use as emergency countermeasures against threats to public health and safety. This applies to pharmaceuticals, medical devices, and PPE-related products (Personal Protective Equipment).
FDA Emergency Use Authorization for Medical Devices
Now for some history. The first event surrounding FDA’s EUA power was the Thalidomide tragedy of the mid-20th century. In the 1950s, this new drug was put into circulation in West Germany and other countries to treat morning sickness. The next decade would reveal that the drug resulted in severe congenital disabilities, with known cases numbering in the tens of thousands in the US alone. Thalidomide’s introduction to the market is remembered as one of the worst public health disasters in recent times.
Fast forward to 1976, when reports of cases involving a new strain of influenza A (the same family of flu viruses that caused the flu pandemic of 1918) prompted fears of a possible “swine flu” pandemic. US President Gerald Ford pushed for a first-ever national vaccination program shortly before starting his reelection campaign. After millions had been vaccinated, the public was alarmed by reports that the vaccine might be causing Guillain-Barré syndrome. G-B is a rare neurological disorder in which the body’s immune system mistakenly attacks part of its peripheral nervous system, causing muscle weakness and sometimes paralysis. Ultimately, a pandemic never materialized.
In the late 1980s, public health experts suggested that an investigational drug called DDI might prove useful for AIDS patients unable to tolerate other medications. Many objected that DDI lacked formal approval and was not guaranteed to be safe and effective; others countered that the risks of breaking protocol by issuing a drug lacking formal approval paled in comparison to the number of lives that could be saved. Impatient with FDA regulators’ conservative approach, Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases, proposed a new system to administer DDI to eligible patients while continuing to study the drug.
Ultimately, it was the War on Terror that would give rise to emergency use authorization. After the events of September 11, 2001, and subsequent anthrax mail attacks. Congress allowed FDA to authorize formally unapproved products for emergency use against a threat to public health and safety (subject to a declaration of emergency by HHS). The record indicates that Congress was focused on the threat of bioterror specifically, not on preparing for a naturally-occurring pandemic.
FDA’s newfound EUA authority would be used relatively sparingly for the first 16 years following its enactment. During that time, its most extensive use was in combating the H1N1 swine flu pandemic of 2009 by authorizing medical equipment and existing influenza drugs.
Around the world and in North America, the Avian influenza A outbreaks occurred in poultry. Outbreaks of some Avian influenza A viruses in poultry have been associated with illness and death in people in Asia, Africa, Europe, the Pacific, and the Near East. The significant outbreaks occurred periodically from 2014-to 2017.
As we all know, COVID-19 arrived in the US in February 2020. HHS Secretary Alex Azar declared the pandemic a national health emergency warranting emergency use of in vitro diagnostics. Since then, FDA has issued nearly 400 EUAs for PPE, medical equipment, in vitro diagnostic products, drug products, and vaccines (compared to 22 EUAs issued in response to H1N1 in 2009). A EUA had never been granted for a brand-new vaccine before; the only vaccine ever to have received a EUA prior to the current pandemic was AVA, an anthrax vaccine that had already been formally approved in 2005.
Lawmakers and policymakers place great value in precedent, whether written or historical. There is almost no precedent to guide the FDA’s use of this relatively new power, let alone during the most significant public health crisis the agency has ever faced. On the contrary, the history of EUAs points up essential dilemmas that aren’t going away and that will have to be grappled with in emergencies to come.
These questions are not unique to FDA. Much has been written generally about the role of agency norms and institutional dynamics in the administrative state. These issues cannot be resolved by looking to the law; they will inevitably require complex judgments about how to balance deference to scientific expertise with public accountability, how to integrate empirical analysis and value judgments, and how to weigh our competing values in times of crisis. FDA’s emergency powers underscore the impact these questions have on the public welfare — and demonstrate that the way we answer them can literally be a matter of life and death.
Summary:
EUAs are just one of several tools the FDA can use to help make critical medical products available quickly during emergencies.
Reference-
https://blog.petrieflom.law.harvard.edu/2021/01/28/fda-emergency-use-authorization-history/
FAQ's
Are Medical Devices regulated by FDA?
The FDA is responsible for regulating medical devices that are used in the United States. This includes devices that are used for diagnosis, treatment, and prevention of medical conditions. The FDA must ensure that medical devices are safe and effective for their intended use.
Medical devices are classified into three different categories: Class I, Class II, and Class III. Class I devices are considered low-risk and do not require a lot of regulation. Class II devices are considered to be of moderate risk and require more regulation. Class III devices are considered to be high-risk and require the most regulation.
The FDA regulates medical devices through a process called premarket review. This is where manufacturers must submit their devices for approval before they can be sold in the United States. The FDA will review the device to make sure it is safe and effective. If the FDA approves the device, it will be given a Unique Device Identification (UDI) number.
Who Regulates Medical Devices FDA?
The U.S. Food and Drug Administration (FDA) is responsible for regulating medical devices. FDA’s Center for Devices and Radiological Health (CDRH) is responsible for ensuring that medical devices are safe and effective.
FDA regulates medical devices through a combination of premarket and postmarket activities. Premarket activities include reviewing device applications, such as premarket approval applications (PMAs) and investigational device exemption applications (IDEs). FDA also conducts inspections of device manufacturing facilities.
Postmarket activities include monitoring device safety through reporting of adverse events and recalls. FDA also conducts postmarket surveillance studies to assess the safety and effectiveness of devices that are already on the market.
What devices does FDA regulate?
The Food and Drug Administration (FDA) regulates a variety of devices, including medical devices, food products, and cosmetics. Medical devices include devices used in the diagnosis, treatment, or prevention of disease. These devices can include, but are not limited to, surgery tools, pacemakers, and prosthetic devices. FDA regulates these devices through the premarket notification process, which requires manufacturers to provide detailed information about their devices to the agency.
Food products include any substances or products that are intended to be eaten or drunk. FDA regulates food products through the food safety process, which requires manufacturers to provide detailed information about their products to the agency. This information includes information about the ingredients in the product, the manufacturing process, and the safety of the product.
Cosmetics are products that are intended to be applied to the body or hair. FDA regulates cosmetics through the cosmetics process, which requires manufacturers to provide detailed information about their products to the agency.