The FDA’s Center for Devices and Radiological Health (CDRH) has 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.
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Federal Food, Drug, and Cosmetic Act terminates or the enforcement policies in certain COVID-19 device guidances are no longer in effect.
CDRH received feedback on the draft guidances, and where possible, CDRH aligned the recommendations in the final guidances, provided additional clarity in areas where comments were received, 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 a 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 decides 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distributing the device after the relevant EUA declaration terminates or the relevant enforcement policy guidance is no longer in effect.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.
The “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency” guidance adds and removes guidances from List 1, and clarifies the start date of the transition period. The "Transition Plan for Medical Devices Issued EUAs Related to COVID-19" guidance provides clarifications regarding in vitro diagnostics, including policies related to Clinical Laboratory Improvement Amendments (CLIA) categorization and waivers, and laboratory-developed tests (LDTs).
There will be a 180-day transition period. Specific information on the scope and the timeline for the transition period can be found in each transition guidance.
The electronic Submission Template And Resource (eSTAR) template can be utilized for 510(k) and De Novo submissions. 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.
