White Paper – Transition Plan for COVID19 EUAs

Jun 14, 2022 | White Paper

White Paper - Transition Plan for COVID19 EUAsWhite Paper on Transition Plan for Medical Devices that fall within enforcement policies and EUAs issued during the COVID-19 Public Health Emergency.

The FDA has provided their thoughts on 180-day transition plans to get back to standard practices (compliance with the Federal Food, Drug, and Cosmetic Act and regulatory requirements) for medical devices issued Emergency Use Authorizations (EUAs) or that fall within Enforcement Policies issued during the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. FDA will tell industry 180 days in advance of the planned termination of Emergency Used Authorizations or withdrawal of the enforcement policies. Manufacturers with devices placed on the market under the COVID-19-related enforcement policies or COVID-19 EUA declarations need to start planning for and working on the relevant submissions to FDA now, especially if they intend to continue distribution of their device(s).