Seeking FDA Emergency Use Authorization for a COVID-19 medical device?

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.

EUA Overview

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 DiagnosticsVentilators 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-19and U.S. Customs and Border Protection regarding importing PPE, diagnostics, and other devices.

EUA advantages and drawbacks include:

Advantages:
  • 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.
Drawbacks:
  • 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:

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.

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.

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.

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 FDA registration and listing 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.

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).

More about 510(k) Clearance

Given COVID-19 social distancing guidelines, we anticipate that telehealth, remote monitoring, and home-use devices will become more necessary and desirable. Many of these types of devices are Class II medical devices that require 510(k) clearance prior to marketing. If your medical device is not eligible for an EUA and is not subject to FDA’s COVID-19 enforcement policies, then consider making a 510(k) submission to gain market access. If you are currently manufacturing and distributing devices under an EUA or other COVID-19 enforcement policy related to COVID-19, then consider planning to submit a 510(k) in parallel if you wish to continue to market and distribute the devices after the COVID-19 public health emergency ends.

FDA premarket notification, a.k.a. 510(k) clearance, is a regulatory pathway that entails making a submission to the FDA demonstrating that your medical device is “substantially equivalent” to a legally market device called the “predicate device.” Your device and the predicate device must have the same intended use. The 510(k) submission needs to reflect that your device is as safe and effective as the predicate device. If your device has different technological characteristics from the predicate device (which is not uncommon), then you provide a summary of how the technological characteristics of your device compare to the predicate device. The 510(k) summary also contains an explanation as to why the differences are not critical to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and why the differences do not affect the safety and effectiveness of the device when used as labeled. Data on nonclinical and clinical tests may be necessary to demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device. See 21 C.F.R. 807.92 for additional premarket notification (510(k)) procedures.

510(k) Frequently Asked Questions:

Once all elements of a 510(k) are completed, it can take days to weeks to prepare and submit a 510(k) to the FDA. FDA typically requires product testing reports to be submitted with your 510(k). Be sure to plan enough time in your schedule to allow for the appropriate testing to be completed.

FDA reviews 510(k) submissions in approximately 90 days (statutory requirement), but the review time can be shorter or longer. FDA can stop the “review clock” if questions or deficiencies arise. It is critical to submit a comprehensive and complete submission package to streamline FDA review.

FDA requires a user fee to be paid for each 510(k) submission. For 2020, the standard fee is $11,594 and the small business fee is $2,899. You must apply and be accepted into the FDA Small Business Program in advance of your 510(k) submission. As noted above, FDA requires medical device manufacturers to pay an annual establishment registration fee. For 2020, the annual establishment registration user fee is $5,236. Apart from the FDA fees, manufacturers should also consider and account for expenses related to the development of a Quality Management System (QMS), product testing, staff time and effort, and legal and other professional services.

Companies manufacturing medical devices must comply with the FDA Quality System Regulation, 21 C.F.R. Part 820. These requirements are not prescriptive and provide the basic framework for companies to follow when implementing a QMS. There are a number of components to an effective QMS, including policies and procedures that outline the company process for various production steps (e.g., design controls, storage and handling, and corrective and preventative actions, etc.).

Read our January 2020 Regulatory Alert to learn more and for a review of the most impactful FDA 510(k) guidance documents issued in 2019.

Our FDA Submissions Expertise.

Drafting regulatory submissions to the FDA requires specialized skills and an intimate knowledge of FDA expectations and requirements. Gardner Law has extensive FDA regulatory submissions experience, including face-to-face and remote interactions with the FDA to discuss and successfully negotiate resolutions to complex submission issues. Our experience and knowledge is based on a hands-on understanding of FDA regulations and guidance documents as well as extensive industry practice.

Amanda Johnston, R.A.C., J.D., is certified by the Regulatory Affairs Professional Society (RAPS) and leads the Gardner Law FDA submissions team. We have worked on nearly every kind of FDA regulatory submission for drugs and medical devices: PMAs, IDEs, 510(k)s, De Novos, NDAs, 513(g) Requests for Designation, Small Business Certification Requests, Breakthrough Designation, annual reports, product change submissions/supplements, and pre-submissions (Q-Subs).

Whether you have a brand new product that you are looking to commercialize or need regulatory assistance with a currently-marketed product, we can help with all aspects of FDA regulatory submissions and strategy. Gardner Law also possesses deep knowledge about product advertising and promotion laws, health care fraud and abuse, compliance programs, sunshine transparency laws, quality management systems, clinical research requirements, FDA enforcement actions, and privacy law that enables us to provide full-service counsel to FDA-regulated companies.

Amanda Johnston, J.D., R.A.C.,
Sr. Attorney, Gardner Law

Amy Fowler, J.D., R.A.C.,
Counsel, Gardner Law

Mark Gardner, M.B.A., J.D.,
Managing Attorney, Gardner Law

Heather Potter, J.D.
Associate Attorney, Gardner Law

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