Virtual Town Hall - Test Development and Validation During the COVID-19 Public Health Emergency
April 26, 2023
- April 26, 2023
- 12:05 PM - 1:00 PM ET
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On April 26, 2023, the U.S. Food and Drug Administration (FDA) held a virtual town hall for test developers to discuss the Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency and Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19) final guidance documents. The guidances outline the FDA's general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations, including the FDA's recommendations for:
- Developing a transition implementation plan for in vitro diagnostics (IVDs) with an EUA,
- Submitting an IVD marketing submission,
- Taking other actions with respect to these IVDs, and
- Additional information related to test developers and COVID-19 tests.
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Federal Food, Drug, and Cosmetic Act terminates or the enforcement policies in certain COVID-19 device guidances are no longer in effect.
The FDA encourages stakeholders to review the two final guidances, attend the CDRH webinar on April 18, and reach out to the FDA if they have questions or concerns. In particular, for manufacturers planning to seek marketing authorization for their devices, the FDA recommends beginning work on a marketing submission, including a transition implementation plan, as described in the guidances.
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
The presentation, printable slides (if applicable), and transcript for this and prior town halls are available for viewing on CDRH Learn under the section In Vitro Diagnostics, sub-section Virtual Town Hall Series.