On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement discretion, in relation to the expected end of the COVID-19 Public Health Emergency (PHE) on May 11, 2023. These guidance documents supplement a schedule that FDA published earlier this month for sunsetting and revising certain guidance documents related to COVID-19. Manufacturers of COVID-19 medical devices should be aware of FDA's transition framework articulated in these guidance documents and plan their post-EUA strategies now to comply with commercial marketing requirements.
During the PHE., FDA made significant efforts to increase the availability of certain medical devices to ensure their availability for patients, healthcare professionals, and the general public. As part of that effort, FDA determined that certain medical devices involved in the COVID-19 response were subject to more relaxed enforcement policies (such as masks, sterilizers, and ventilators) that increased their availability in the US. The agency also issued EUAs to specific manufacturers of devices (such as for in vitro diagnostic and blood purification devices) or issued umbrella EUAs for the same reason. The agency further issued several guidance documents exercising its enforcement discretion, such as its temporary policy for face shields, surgical masks, and respirators during the PHE.
The first guidance document, concerning EUA medical devices, confirms that the end of the PHE will not trigger automatic termination of EUAs. Instead, these EUAs will remain operative as long as (1) the applicable EUA declaration issued under section 564 of the Food, Drug, and Cosmetic Act (FD&C Act) remains in effect, and (2) the specific EUA has not been terminated. The Biden administration has not yet announced an expected end date to the section 564 emergency declarations; the guidance confirms that the Secretary of Health and Human Services (HHS) intends to publish advanced notice 180 days before each of the section 564 declarations is terminated.
The guidance document also establishes a process for the transition of EUA products once the expected end date of the section 564 emergency declaration is announced. For manufacturers that wish to continue distributing the devices beyond the EUA termination date, FDA will not object to the continued distribution of devices if (1) the manufacturer has submitted a marketing submission that is accepted by FDA prior to the EUA termination date, and (2) FDA has not taken final action on the marketing submission. The FDA's guidance also provides information specific to laboratory developed tests and EUA-authorized in vitro diagnostics subject to Clinical Laboratory Improvement Amendments of 1988 (CLIA) categorization and waivers.
The second guidance document addresses the transition plan for medical devices that were subject to certain enforcement policies issued during the PHE. The FDA confirmed that the policies listed in the guidance will remain in effect until 180 days after the end of the PHE, November 7, 2023. The guidance outlines a three-phase plan for ensuring that any devices marketed under a specifically listed enforcement policy will be able to be marketed lawfully after the termination of those enforcement policies. During the 180 day period, manufacturers who are interested in continuing to market their devices must submit a marketing submission and bring the device into compliance with adverse event reporting requirements in 21 CFR Part 803, reports of corrections and removal requirements in 21 CFR Part 806, and registration and listing requirements in 21 CFR Part 807 Subparts B-D. While the marketing submission is pending, FDA may continue to exercise enforcement discretion for certain other regulatory requirements identified in the guidance; however, after the FDA has taken final action on the submission, the manufacturer must comply with all applicable requirements.
In all cases, FDA recommends that manufacturers of EUA medical devices plan their post-EUA strategies now. Additionally, certain scenarios identified in the guidance documents call for the manufacturers to provide an advanced "Notification of Intent" or "Transition Implementation Plan" to help ensure coordinated handling of these devices. The agency is available to resolve product-specific questions through the Q-Submissions Program and by requesting timely exemptions and variances, when appropriate.
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