This alert summarizes how to determine whether your device is eligible for an Emergency Use Authorization (EUA), how to seek an EUA, regulatory hurdles, and options for makers of devices that are not EUA-eligible
FDA has marshaled its EUA authority in the fight against COVID-19. This has allowed manufacturers and distributors to respond to COVID-19-related shortages by getting desperately needed devices and testing to market quickly. Authorizations have been granted for Personal Protective Equipment (PPE), In Vitro Diagnostics, Ventilators and other medical devices. The situation is fluid and evolving daily. It is likely that additional EUA declarations will be issued for more product categories. Check the FDA website for the latest information. See helpful FDA links below.
Qualifying for an EUA
An EUA request may be made for a medical device, drug or biologic. This alert focuses on devices (including diagnostics). In order to qualify for an EUA a product must meet all of the following requirements per Section 564 of the Federal Food, Drug, and Cosmetic Act.
- An DHHS declaration related to a “serious or life-threatening disease or condition” exists (e.g., COVID-19).
- That based on evidence available to the Secretary [of DHHS, Alex Azar] that it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing the disease or condition.
- The known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product.
- There is no adequate, approved, and available alternative to the product for diagnosing, preventing, or treating such disease or condition (FDA has interpreted this last prong to mean that if there are insufficient supplies of an approved product (e.g., masks) that similar unapproved products may still qualify for an EUA).
FDA fleshed these requirements out in its 2017 EUA guidance.
Importing EUA Devices
FDA has broad and flexible authority to refuse product entry into the United States. Therefore, importers of PPE, diagnostic tests, and other products must be mindful of important FDA and U.S. Customs and Border Protection importing requirements. See recent statements issued by the FDA on COVID-19 and U.S. Customs and Border Protection regarding importing PPE, diagnostics, and other devices.
EUA advantages and drawbacks
- Allowing qualified products to gain market access rapidly and getting them into the hands of health care professionals in order to address the emergency.
- Inexpensive—there are no user fees.
- FDA has authority to waive certain FDA requirements for the duration of the public health emergency, e.g., GMPs, QSR, UDI requirements.
- Hospitals and clinics may be reluctant (or not allowed) to purchase products that are not formally cleared or approved by the FDA.
- EUAs are temporary. Once the EUA declaration is terminated, the EUAs based on the declaration will no longer be in effect and manufacturers and distributors must comply with all FDA requirements, including obtaining FDA approval or clearance, in order to continue marketing.
- For most EUAs, FDA requires the submission of a substantial amount of information. Required information includes, but is not limited to, device specifications, safety and efficacy information, a description of the unmet needs related to COVID-19, the status of your quality system, and Instructions for Use. Companies also need to create compliant labels and labeling.
EUA Frequently Asked Questions:
- What products are eligible under the EUA?
Refer to FDA’s current list of EUAs. You should contact the appropriate FDA Center before submitting an EUA request. We have found that FDA is willing to entertain EUA requests for other types of products if there is a true unmet need tied to COVID-19, for example.
- How long does the EUA process take?
FDA does not commit to any specific timing for review of EUAs, but they are prioritizing them. Consider collaborating with FDA upfront with pre-EUA activities and a pre-EUA submission to ensure a smooth and efficient review process. Contact the FDA early on in the process.
- How long does the EUA last?
Until the EUA declaration is terminated, which is the earlier of either: (1) a determination by the DHHS Secretary that the public health emergency has ceased; or (2) the product is no longer “unapproved” for the use covered by the EUA.
- Are there any fees?FDA registration and listing
FDA does not charge a fee for submitting an EUA request (or pre-EUA request) but there may be considerable costs associated with staff time needed to compile the EUA request and is likely required. The 2020 annual registration fee is $5,236. If the submitter does not have a QMS, they may need to deploy one—which is a significant endeavor.
- What if my medical device is not eligible for an EUA?
FDA is exercising enforcement discretion for some products not specifically covered by an EUA. Check the FDA COVID-19 website often to see if there is an applicable enforcement policy. You may also consider another pathway to market, e.g., premarket notification 510(k), de novo classification, or premarket approval (PMA).