Keys to managing your successful EUA transition.
On May 11, 2023, the COVID-19 public health emergency (PHE) declared under section 319 of the Public Health Service (PHS) Act expired. However, it is important to note that the Emergency Use Authorization (EUA) declaration under section 564 of the United States (U.S.) Federal Food, Drug & Cosmetic (FD&C) Act is distinct from the PHE and the EUA remains in effect, allowing FDA to use their EUA authority to authorize new tests.
FDA issued two final guidance documents earlier this year on March 27th outlining the next steps manufacturers should take for products granted an EUA during the COVID-19 pandemic. Of the two, FDA’s document entitled “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)” applies to devices, including in vitro diagnostics (IVDs), and provides guidance both for manufacturers that intend to continue distribution after the transition period, as well as manufacturers who do not intend to continue distribution, but who may have some distributed devices still in use.
As it is not yet known when the EUA declaration under section 564 will be terminated, FDA guidance is recommending manufactures begin preparing for the termination date. This includes developing a Transition Implementation Plan, determining the appropriate regulatory pathway, and submitting for market authorization if they wish to continue distribute their product when the EUA declaration ends.
THE 180-DAY WINDOW
As noted, the EUA declaration is distinct from the PHE and currently remains in effect. The FD&C Act requires the Health and Human Services (HHS) Secretary to provide advance notice that an EUA declaration will be terminated (which terminates all EUAs issued under that declaration) and to publish such notice in the Federal Register.
HHS will issue 180-day advance notice of termination of each device EUA declaration either individually or simultaneously. In this transition period, device manufacturers who intend to market and distribute COVID-19 IVDs after the termination of their EUA must prepare and submit traditional regulatory marketing applications (510(k), De Novo, or PMA).
After the 180 days, devices may continue to be labeled and distributed as previously authorized under the EUA provided that the manufacturer has submitted an administratively complete application, excluding pre-submissions, and the application has been accepted by FDA for substantive review.
TRANSITION IMPLEMENTATION PLAN
FDA recommends inclusion of a “Transition Implementation Plan” in the marketing submission cover letter. This plan should address the manufacturer’s intended approach for devices that have already been distributed, (i.e., finished, labeled devices that are no longer in the manufacturer’s possession but are in a 3rd party’s inventory, in distribution in the US supply chain, or in possession of the end user).
In addition to an estimate of the number of devices in distribution, the Transition Implementation Plan should cover the actions that will be taken for either regulatory outcome:
- In the event of a negative decision, the plan should include a disposition plan, or a rationale and subsequent considerations should the manufacturer choose to leave their device in distribution.
- In the event of a positive decision, pathways for stakeholder notification, UDI compliance, registration and listing updates, and labeling updates should be specified.
QUALITY MANAGEMENT CONSIDERATIONS
Non-traditional device manufacturers that may not have a quality system in place that fully complies with 21 CFR Part 820, but who wish to continue to distribute their devices after the EUA termination date, may choose to request an exemption or variance from a device QS requirement as outlined in 21 CFR 820.1(e) and section 520(f)(2) of the FD&C Act within 90 days of publication of the advance notice of termination of the EUA declaration.
CLIA CATEGORIZATION CONSIDERATIONS
IVDs authorized under an EUA are generally authorized for use in specific settings, such as those certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as laboratories, that meet the requirements to perform high or moderate complexity tests, or for use at the point-of-care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
- IVDs with an EUA specifying use in laboratories CLIA-certified to perform moderately complex tests will follow the typical categorization process and FDA will categorize the device’s complexity immediately following final action on the submission.
- For IVDs authorized under an EUA for use in CLIA-waived patient care settings, FDA intends to accept submissions under Dual 510(k) and CLIA Waiver or Dual De Novo and CLIA Waiver
- IVDs authorized under an EUA for home use will be categorized as waived without the need for a CLIA Waiver by Application, provided that the marketing submission is cleared, approved, or authorized for home use.
FDA is recommending that any marketing submission that may necessitate a CLIA categorization decision (e.g., tests intended for use in moderate complexity laboratories or in CLIA Certificate of Waiver settings) be submitted as soon as possible to facilitate FDA’s review of the marketing submission and CLIA categorization request (or CLIA Waiver by Application) prior to the termination of the EUA declaration to reduce the potential for disruption in distribution and use.
FOR MANUFACTURERS DISCONTINUING PRODUCT MARKETING
FDA also encourages manufacturers who do not intend to keep their devices on the market to follow a Transition Implementation Plan and to work closely with device distributers, healthcare facilities, healthcare providers, patients, and consumers to assist in transition planning and prevent supply chain disruptions.
If a manufacturer does not intend to continue to distribute its IVD beyond the EUA termination date, the disposition and use of already-distributed devices will continue to be allowed within the product expiry listed at the time of termination and in a manner consistent with the EUA that was in effect. All applicable legal requirements such as adverse event reporting must be upheld. Manufacturers may also choose to voluntarily withdraw their devices from the market prior to EUA termination.
FDA is encouraging manufacturers planning to pursue 510(k) or De Novo pre-market submission authorization for their tests to initiate discussions with the Agency through the Q-submission pre-submission process and to begin working on their marketing submissions, including their Transition Implementation Plans, as soon as possible and prior to the 180-day advance notice of termination.
Marketing submissions must be submitted to and accepted by the FDA before the EUA termination date; on the date of the EUA termination, all EUAs issued under that declaration will be terminated. The enforcement policy in the EUA transition guidance will be in place only for devices that have a marketing submission under review by FDA.
It is important to note that there may be an overflow of marketing submissions as we move closer to the end of the estimated 180-day period, and manufacturers are well advised to submit applications as early as possible to help expedite a prompt decision from FDA.
HOW BEAUFORT CAN HELP
Beaufort’s team of regulatory, quality and clinical experts can provide comprehensive regulatory strategy as well as submission and clinical trial support to afford a successful 510(k), De Novo or Dual CLIA wavier pre-market submission.
Whether for OTC, POC, or laboratory use, we have supported manufacturers throughout the pandemic with their COVID-19 diagnostic test EUAs. We are now helping clients strategize, draft submissions and collect data to expedite their FDA market authorization — and can put this same experience to work for you.