iOn March 27, 2023, the U.S. Food &Drug Administration (FDA) released two final guidance documents to assist with the transition of medical devices that were legally distributed: (1) subject to certain enforcement policies issued during the COVID-19 public health emergency (PHE) or (2) Emergency Use Authorizations (EUAs). Manufacturers, distributors, and industry stakeholders that have products subject to one of these pathways should review the agency guidance if they wish to continue marketing the products. If an entity is not sure whether an EUA applies to a product, FDA has generated a full list at this site.
On January 31, 2020, the Department of Health and Human Services (HHS) first determined a public health emergency (PHE) existed because of COVID-19. This PHE determination has been renewed many times, the most recent on February 9, 2023. However, change is approaching for the regulated industry since HHS recently announced that it is preparing to declare an end to the PHE for COVID-19 on May 11, 2023. As a result, certain industry sectors will be impacted, particularly those that manufacture or distribute medical devices subject to FDA enforcement polices and EUAs issued during the PHE.
During the PHE, the FDA issued numerous EUAs and enforcement policies allowing manufacturers to quickly develop and distribute products such as masks, medical devices, and ventilators. The EUAs and enforcement policies provided flexibility for manufacturers to avoid the standard requirements for medical devices, such as premarket notifications, that otherwise could lead to significant delay in reaching the market. These flexibilities helped non-traditional manufacturers to provide much-needed medical devices to aid in the nationwide COVID-19 response.
(1) Enforcement Polices Guideline
The HHS is scheduled to end the PHE on May 11, 2023 and the FDA phased transition is scheduled to take effect 180 days later. If the HHS expiration date remains the same, the FDA process will begin on November 7, 2023. The FDA enforcement policy guidelines separates the transition of enforcement polices into three phases that the industry should be aware of to remain in compliance with applicable regulations:[1]
· Phase 1 begins on May 11, 2023, the current expiration date for the PHE. Manufacturers should continue to follow reporting requirements as described in 21 C.F.R. Part 803, which require that the manufacturer submit a report no later than 10 work days after the day the manufacturer became aware the device could cause or contribute to serious injury, among other reporting requirements.
· Phase 2 begins 90 days after the implementation date, August 9, 2023, and requires that before this date manufacturers should: (1) comply with 21 C.F.R. Part 806 on reporting corrections and removals, and (2) if planning to continue to distribute devices after Phase 2, follow 21 C.F.R. Part 807 B-D on registration and listing requirements.
· Phase 3 begins after the 180-day window from the expiration date of the PHE (currently Phase 3 will begin on November 7, 2023). After this date, enforcement policies identified in List 1[2] will no longer be in effect. Importantly, to continue distributing devices after Phase 3, manufacturers must have submitted a marketing submission to the FDA and the FDA must have accepted it before Phase 3 begins.
The FDA recommends that manufacturers wishing to continue distributing medical devices submit a “Transition Implementation Plan” with their marketing submissions that address the manufacturer’s plans for addressing devices already distributed[3] well in advance of the initiation of Phase 3.
(2) EUAs Guideline
For products subject to EUAs, the EUA will remain in effect until the applicable EUA declaration is terminated. While the HHS declared the PHE, this was a separate declaration from those that led to the EUAs. The specific EUA declarations must be terminated by FDA before they are no longer in effect. Notice of such terminations will be provided in the Federal Register, so industry stakeholders should continue to monitor.
In the interim, FDA is statutorily mandated to provide advance notice for the termination of EUAs to allow for a sufficient period for disposition of unapproved products or disposition of labeling and information related to the EUA for approved products engaging in an unapproved use. To meet its mandate, FDA issued a Transition Plan for Medical Devices Issued EUAs Related to Coronavirus Disease 2019 (COVID-19).
Devices Already in Commerce: The FDA recommends that manufacturers submit a notice of intent as soon as possible, stating whether the manufacturer plans to continue making and marketing its product or will discontinue the device. If the manufacturer does not intend to continue to distribute its device beyond the EUA termination date, it may discontinue its product. However, the FDA does not intend to object to the disposition and use of already distributed devices of the following:
· single-use, non-life supporting/non-life-sustaining devices (e.g., face masks and in vitro diagnostics) that were distributed before the EUA termination date;
· reusable, non-life-supporting/non-life-sustaining devices (e.g., non-invasive remote patient monitoring devices) that are either restored to an FDA-cleared or -approved version or have a copy of updated labeling; and
· reusable life-supporting/life-sustaining devices (e.g., ventilators) that either restored to an FDA-cleared or -approved version or have a copy of updated labeling.[4]
Devices Post EUA-Termination Date: To continue to sell products after EUA termination, manufacturers need to prepare and submit a marketing submission, a “Transition Implementation Plan,” as soon as possible. The FDA recommends that marketing submissions include a cover letter that addresses the plans the manufacturer has for devices already distributed in the case it receives a positive decision on its marketing plan and plans in the case of a negative decision on the marketing submission. FDA lists several items to include in the plan, including the estimated number of devices under an EUA currently in U.S. distribution and an explanation of the manufacturer’s benefit-risk plan for disposition of already distributed products or a rationale for leaving the products in place. Rationale considerations include:
· a process for notifying patients, consumers, healthcare facilities, healthcare providers, and device distributors of the devices’ regulatory status;
· a process and timeline for restoring already distributed devices to an FDA-cleared or -approved version;
· process and timeline for updated labeling;
· and a description of the maintenance plan for already distributed devices.
Discontinuation of Devices: Manufacturers are expected to discontinue distribution of devices as follows: if on the EUA termination date the manufacturer has not submitted a marketing submission that has been accepted by the FDA, or the manufacturer receives a negative decision on its marketing submission as the FDA’s final action, or the manufacturer withdraws its submission or fails to provide a complete response to an FDA request for additional information within the allotted time identified by the FDA in its letter. Manufacturers must also stay apprised of any applicable legal requirements, such as adverse event reporting under 21 C.F.R. Part 803 and continue to comply with such requirements for the duration in which they remain applicable, which could be past the cessation of distribution.
After the EUA termination date, FDA will exercise enforcement discretion for the continued distribution of devices subject to applicable EUAs provided that (1) the manufacturer has submitted its marketing submission, (2) the FDA has accepted the marketing submission before the EUA termination date, and the (3) FDA has not taken final action on the marketing submission.
FDA recognizes that non-traditional manufacturers may have challenges adapting to the quality system requirements that were not required in full under the scope of EUAs. Such manufacturers should coordinate early with FDA and explore if any exemptions or variances are applicable to their product. FDA cautions that any exemptions should be requested within 90 days of publication in the Federal Register of the termination of the EUA in question.
Specifically, manufacturers of certain reusable life-sustaining equipment, such as ventilators and extracorporeal membrane oxygenation systems, under EUAs are requested to submit information to the FDA on whether they intend to submit marketing submissions to continue distributing.
Conclusion
Manufacturers of medical devices should pay close attention to the PHE end date to ensure it remains the same as anticipated. Moreover, manufacturers wishing to continue distribution of devices must investigate the requirements of each phase to stay in compliance and submit marketing submissions to the FDA before Phase 3 to stay in operation. If you have any questions regarding these transition plans, please contact the authors of this post.
FOOTNOTES
[1] A more fulsome guideline on which guidance documents will no longer be in effect after the expiration of the PHE declaration can be found at https://www.federalregister.gov/documents/2023/03/13/2023-05094/guidance-documents-related-to-coronavirus-disease-2019-covid-19.
[2] List 1 in the guidance includes enforcement policies for Remote Ophthalmic Assessment and Monitoring Devices; Infusion Pumps and Accessories; Face Shields, Surgical Masks, and Respirators; Gowns, Other Apparel, and Gloves; Sterilizers, Disinfectant Devices, and Air Purifiers; Ventilators and Accessories and Other Respiratory Devices; Modifications to FDA Cleared Molecular Influenza and RSV Tests; Coagulation Systems for Measurement of Viscoelastic Properties; and Viral Transport Media.
[3] Defined as finished devices that are labeled and in distribution in the U.S. supply chain or are in the possession of the end uses.
[4] See the EUA guidance at page 16 for more detailed instructions.
