The Center for Devices and Radiological Health (CDRH) of the FDA has released two final guidance documents to help with transition plans for medical devices that have received Emergency Use Authorizations (EUAs) or fall under specific enforcement guidelines to support the response to the Coronavirus Disease 2019 (COVID-19) pandemic. The FDA has approved the draft guidelines released in December 2021 to facilitate the availability of medical devices, including in vitro diagnostic tests, personal protective equipment, and ventilators. CDRH is also providing transition guidance to ensure an orderly and transparent transition to normal operations.
The Final Guidelines
CDRH has adapted its policies and decision-making to address public health threats, with the Federal Food, Drug, and Cosmetic Act terminating enforcement policies in certain EUAs and enforcement policies no longer in effect. CDRH aligned recommendations, provided clarity in areas where comments were received, and helped ensure the approach is less burdensome on CDRH and stakeholders. This simplified approach requires
- The FDA is removing recommendations for interim labelling for devices authorized by a EUA related to COVID-19, expecting manufacturers to comply with all applicable requirements, including any labelling updates.
- Importance of providing clarity on recommendations for physical and/or electronic labelling.
- The EUA provides guidance on how to dispose of and use already distributed devices after the relevant EUA declaration terminates or the relevant enforcement policy guidance is no longer in effect.
- Providing real-world evidence to support marketing submissions, interactions with CDRH, collaboration with stakeholders, and example scenarios.
- The Start date of the transition period was made explicit in the Transition Plan for Medical Devices that Fall under Enforcement Policies Established During the COVID-19 Public Health Emergency guideline.
- In vitro diagnostics, including CLIA category and exemptions, and LTDs are clarified in the Transition Strategy for Medical Devices Issued EUAs Relevant to COVID-19 guidelines.
Manufacturers need to submit marketing materials right away.
The CDRH encourages anyone who intends to apply for marketing authorization for a device for which a EUA in relation to COVID-19 was granted to start putting together their marketing submission, including their transition implementation. Companies planning marketing submissions can contact CDRH early on and use the electronic Submission Template and Resource (eSTAR) template for 510(k) and de novo submissions, thanks to the pre-submission procedure. The eSTAR template should be used by submitters in order to enable them to offer thorough, high-quality data for CDRH’s premarket evaluation. In addition, CDRH advises including a transition strategy in the marketing application. CDRH will continue to offer leadership, knowledge, direction, and information to stakeholders while facilitating a smooth and transparent transition to regular operations.
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Source: FDA Guidelines to Assist with COVID-19-Related Medical Device Transition Plans
