Test Development and Validation During the COVID-19 Public Health Emergency

The U.S. Food and Drug Administration (FDA) will host a virtual town hall on 26 April 2023 for test developers to discuss the final guidances for the:

• 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)

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.

No registration is required.

Time: 12:05 p.m. – 1 p.m. ET
To ensure you are connected, please join 15 minutes before the start of the virtual town hall.

Please click the link below to join the webinar:

• https://fda.zoomgov.com/j/1612083563?pwd=NklWOE1jUlU2dUVlNWtvQTNkdTM5UT09External Link Disclaimer
• Passcode: ^8@HvK

You will have an opportunity to ask questions live during the virtual town hall and you may also submit questions in advance by emailing CDRHWebinars@fda.hhs.gov.

• Please submit questions by Monday 12 p.m. ET before the Wednesday virtual town hall.
• In the subject line of the email, type Questions for the Virtual Town Hall Test Development and Validation During Public Health Emergencies.

Background:

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Federal Food, Drug, and Cosmetic Act terminates or the enforcement policies in certain COVID-19 device guidances are no longer in effect.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