The following is attributed to Jeff Shuren, M.D., J.D., director of the FDA's Center for Devices and Radiological Health and William Maisel, M.D., MPH, director of the Office of Product Evaluation and Quality (OPEQ), CDRH
FOR IMMEDIATE RELEASE
March 24, 2023
Today, the FDA's Center for Devices and Radiological Health (CDRH) issued two final guidance documents to assist with transition plans for medical devices that were issued emergency use authorizations (EUAs) or fall within certain enforcement policies issued to support the response to the Coronavirus Disease 2019 (COVID-19) pandemic. CDRH finalized these transition guidances after receiving meaningful feedback and public comments on the draft guidances that were issued in December 2021.
Since the beginning of the COVID-19 pandemic, CDRH has taken a number of proactive steps to help facilitate the availability of critical medical devices, including in vitro diagnostic tests, personal protective equipment, and ventilators. The FDA issued more than 950 EUAs for medical devices, which have enabled access to over 430 different medical devices to help diagnose, treat, or prevent COVID-19. CDRH also issued guidance documents, including enforcement policies, to help expand the availability of certain devices, including ventilators, remote monitoring devices, surgical masks, gloves, and more, to help patients, health care providers, and other health care professionals access devices for COVID-19-related uses.
Given the magnitude of the response to the COVID-19 pandemic, CDRH is taking steps to assist stakeholders, including industry, health care professionals, and patients, who may need time to transition from certain temporary emergency measures. CDRH developed these transition guidances to help avoid disruption in device supply and facilitate compliance with applicable requirements, while providing stakeholders with recommendations and an appropriate transition period to ensure an orderly and transparent transition to normal operations.
What is New about the Final Guidances
While CDRH has continued to adapt its policies and decision-making during the COVID-19 pandemic based on emerging science and data, these EUAs and enforcement policies were intended to be temporary in order to help address an immediate public health threat. The final transition guidances provide recommendations and clarity for medical device manufacturers that may or may not want to continue to distribute their devices after the relevant device EUA declaration related to COVID-19 under section 564 of the Federal Food, Drug, and Cosmetic Act terminates or the enforcement policies in certain COVID-19 device guidances (see "List 1") are no longer in effect. CDRH received helpful feedback on the draft guidances, and where possible, CDRH aligned the recommendations in the final guidances, provided additional clarity in areas where we received comments, and helped ensure the approach was least burdensome on CDRH and stakeholders. This streamlined approach includes:
- Removing recommendations for interim labeling for devices that were authorized under an EUA related to COVID-19. As described in the final transition guidances, the FDA expects manufacturers to comply with all applicable requirements for the device/manufacturer, including any labeling updates, after the FDA's decision on the marketing submission for a device.
- Providing clarity on recommendations regarding physical and/or electronic copies of updated labeling.
- Providing clarity on recommendations regarding the disposition and use of already distributed devices where the manufacturer does not intend to continue distributing the device after the relevant EUA declaration terminates or the relevant enforcement policy guidance is no longer in effect.
- Providing clarifications regarding use of real-world evidence in marketing submissions, interactions with CDRH, collaboration with stakeholders during the transition process, and example scenarios.
- For the "Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency" guidance: added and removed guidances from List 1, and clarified the start date of the transition period.
- For the "Transition Plan for Medical Devices Issued EUAs Related to COVID-19" guidance: provided clarifications regarding in vitro diagnostics, including policies related to Clinical Laboratory Improvement Amendments (CLIA) categorization and waivers, and laboratory developed tests (LDTs).
We recognize that it will take time for device manufacturers, device distributors, health care facilities, health care providers, patients, consumers, and the FDA to adjust from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations. Importantly, as outlined in the final transition guidances, there will be a 180-day transition period for these devices to help avoid disruption in device supply and help ensure an orderly and transparent transition. Specific information on the scope and the timeline for the transition period can be found in each transition guidance.
Manufacturers Should Submit Marketing Submissions Now
Device manufacturers that are planning to seek marketing authorization for their device that was issued an EUA related to COVID-19, or that falls within an enforcement policy issued during the COVID-19 public health emergency (see "List 1"), should begin working on their marketing submission, including their transition implementation plan, as described in the transition guidances. CDRH encourages those who want to continue marketing their device, and need to prepare a marketing submission, to use this transition period wisely, and submit a pre-submission, if needed. The pre-submission process allows companies preparing marketing submissions to have early interactions with CDRH.
Additionally, sponsors may utilize the electronic Submission Template And Resource (eSTAR) template for 510(k) and De Novo submissions. While it is currently voluntary for De Novo submissions, and currently voluntary for 510(k) submissions until October 2023, it is a useful tool designed to help submitters provide quality, comprehensive data for CDRH's premarket review. With a standardized format, submitters can ensure their marketing submissions are complete, and CDRH can conduct premarket reviews more efficiently to help promote timely access to safe, effective, and high-quality medical devices. Additionally, as stated in the transition guidances, CDRH recommends that the marketing submission include a transition implementation plan; while the eSTAR template does not contain a section for the transition implementation plan, the guidances recommend including the plan in the cover letter of the marketing submission.
CDRH intends to facilitate an orderly and transparent transition to normal operations and will continue to provide leadership, expertise, guidance, and information to stakeholders. We encourage anyone with questions to reach out and to attend our forthcoming webinar on April 18.
- Coronavirus Disease (COVID-19)
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
- Webinar on Guidances on COVID-19 Transition Plans for Medical Devices - April 18, 2023