On March 27, 2023, the U.S. Food & Drug Administration (FDA) released two final guidance documents to assist with transitioning medical devices: (i) that were subject to certain enforcement policies issued during the COVID-19 Public Health Emergency (PHE), and (ii) that were issued emergency use authorizations (EUAs). These guidance documents finalize the corresponding draft guidance documents that were issued on December 23, 2021. In a previous post, we discussed several key takeaways from the draft versions of these transition guidance documents.
“Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” Final Guidance
In the “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency” final guidance, the FDA discusses the transition plan for medical devices that were subject to certain enforcement policies issued during the PHE. FDA confirms that the policies listed in the guidance, which are set forth in List 1 thereto, will remain in effect until 180 days after the end of the PHE. The PHE declaration is scheduled to expire on May 11, 2023. Therefore, the enforcement policies identified in List 1 will no longer be in effect after November 7, 2023.
In the guidance, the FDA provides recommendations for a “phased transition process” with respect to devices that fall within the expiring COVID-19 PHE enforcement policies. The FDA summarizes the three phases of the 180-day transition plan as follows:
- Phase 1 (May 11, 2023): Manufacturers should follow adverse event reporting requirements as described in 21 C.F.R. § 803.
- Phase 2 (August 9, 2023): If planning to continue to distribute their devices after Phase 2, manufacturers need to adhere to registration and listing requirements (21 C.F.R. § 807 Subparts B-D) and should adhere to requirements associated with reports of corrections and removals (21 C.F.R § 806).
- Phase 3 (November 7, 2023): In Phase 3 the enforcement policies identified in List 1 will no longer be in effect. FDA states it does not intend to object to continued distribution of devices where a required marketing submission has been submitted and accepted by FDA before the start of Phase 3, and FDA has not taken a final action on the marketing submission. FDA further indicates that it does not intend to object to the devices not complying with certain unique device identification (UDI) systems requirements and other applicable labeling requirements described in 21 C.F.R. § 801.
FDA recommends manufacturers submit a “Transition Implementation Plan” with their marketing submissions (if needed) that addresses the manufacturer’s plans for addressing devices already distributed, which plans need to include actions to be taken in the event either a positive or negative decision by the FDA on the marketing submission. Furthermore, FDA strongly encourages manufacturers to complete and submit these submissions well in advance of the start of Phase 3. This is recommended to avoid potential delays created by a large influx of new submissions.
“Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)” Final Guidance
In the “Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)” final guidance (“EUA Guidance”), the FDA confirms that the end of the PHE will not automatically terminate EUAs. Instead, these EUAs will remain in effect until the relevant EUA declaration is terminated, or the FDA otherwise revokes a specific EUA.
The EUA Guidance includes recommendations for certain reusable life-supporting or life-sustaining devices, devices distributed after the EUA termination date, laboratory developed tests, and EUA-authorized in vitro diagnostics subject to Clinical Laboratory Improvement Amendments of 1988 categorization and waivers. With respect to certain reusable life-supporting or life-sustaining devices, FDA requests manufacturers of such devices to submit information regarding whether or not they intend to submit marketing submissions to continue distributing the device(s) after the applicable EUA termination date.
Furthermore, FDA states in the EUA Guidance that it will not object to the continued distribution of devices after the device’s applicable EUA termination date 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. Therefore, it is recommended that manufacturers of these devices submit marketing submissions well in advance of the EUA termination date.
Foley is here to help you address the short- and long-term impacts in the wake of regulatory changes. We have the resources to help you navigate these and other important legal considerations related to business operations and industry-specific issues. Please reach out to the authors, your Foley relationship partner, or to our Health Care Practice Group with any questions.