FDA Issues Final Guidances to Assist with Transition Plans for COVID-19-Related Medical Devices

Therapeutic Goods Medical Devices
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Drug, and Cosmetic Act terminates or the enforcement policies in certain COVID-19 device guidances (see “List 1”) are no longer in effect.
According to FDA, device manufacturers that are planning to seek marketing authorization for their device that was issued a 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 guidance.
Need to know more about Medical Devices regulation changes? Get in touch with RegASK’s experts.
Contact RegASK for more details Read more

Have a
regulatory affairs

Regulatory Affair Icon