Does your organization have items that were allowed in emergency use of authorization, use approval to get to showcase? If you need to keep those items available post-EUA, do you have any plan what you want to do now to get prepared? This article will spread some light on above cited questions and will brief you about EUA (Emergency Use of Authorization)
Emergency Use of Authorization (EUA) overview:
EUA i.e. Emergency use Authorization is a tool. Medical devices or products are authorized for use under specific circumstances. FDA uses this (EUA) on a temporary basis to fulfil urgent medical needs during public health emergencies. EUA is a pathway; it is not the approval or clearance for the product; it just an authorization for public health during emergencies. The origin of EUA lies mostly in the pharmaceutical and biotechnological field.
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The EUA authority is separate and distinct from use of a medical product under an investigational application (i.e., Investigational New Drug Application (IND) or Investigational Device Exemption (IDE)), section 561 expanded access authorities and section 564A emergency use authorities discussed in section IV of this guidance, Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS (Health & Human services) declares that an emergency use authorization is appropriate, FDA may authorize 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 certain criteria are met, including there are no adequate, approved and available alternatives.
Products such as mask, PPE (Personal Protective equipment) , gowns, surgical gloves, ventilators, respirators as well as many of these products were marketed under Emergency Use authorization (EUA). As per the new guidance manufacturers need to ensure that the products will be lawfully marketed once the public health emergency is declared over.
FDA’s Guidance on Emergency Use of Authorization ( EUA):
On February 22,2022 the US FDA hosted a webinar about the draft guidance on COVID-19 transition plans for medical devices. Due to pandemic the supply chain is disrupted, as demand for certain devices exceeds supply. To protect public health FDA has issued emergency use authorization for more than 800 medical devices including COVID-19 tests and PPE.
FDA Draft Guidance for Medical Devices Prepares for End of Pandemic, The FDA EUA guidance is about giving medical device manufacturers a year\’s notification prior to ending crisis to use approvals post-pandemic. While the current pandemic response remains the FDA\’s top priority, to provide clarity to all manufacturers, the FDA issued two draft guidance documents to provide recommendations to manufacturers that may or may not want to continue to distribute medical devices after the relevant EUA declaration is terminated.
- One addresses the transition plan for medical devices being marketed under an Emergency Use Authorization (EUA) and
- the other describes the transition plan for medical devices on the market subject to enforcement discretion.
Get prepared for post EUA -(Emergency Use of Authorization):
- The first thing that can be done is an examination of an ongoing EUA product and related documentation against what might commonly be expected for this kind of medical devices. This examination will give you an idea what work will be required. This analysis will help to formulate a regulatory strategy.
- The manufacturer of EUA products should address the previous guidelines for GMPs, post market surveillance, quality frameworks
- Manufacturers should submit any Pre-Submissions with the understanding that their device will no longer be authorized for emergency use beginning on the EUA termination date.
Whenever an EUA for a medical device is taken back, the device will never be marketed legally except it has gotten approval from the FDA.
Emergency Use of Authorization( EUA) devices that have not been \”converted\” to traditional medical devices via traditional regulatory pathways will need to be removed from the market. Operon medical device consultancy always work hard for the betterment of their client and provide regulatory updates. To know more regulatory updates you can also subscribe our Newsletter.
