RQMIS can help prepare your transition plans and help you through the guidelines for FDA clearance.
To learn more please call us at 978-358-7307, or just click the button below.
March 2023, the U.S. Food and Drug Administration finalized two guidances: 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).
These guidances outline the FDA’s general recommendations to transition from certain policies adopted and operations implemented during the COVID-19 pandemic to normal operations. The recommendations include information for devices that fall within certain enforcement policies issued during the COVID-19 public health emergency (PHE) under section 319 of the Public Health Service Act and devices issued EUAs related to COVID-19 under section 564 of the Federal Food, Drug, and Cosmetic Act, including:
- Developing a transition implementation plan,
- Submitting a marketing submission, and
- Taking other actions with respect to these devices.
There will be a 180-day transition period for impacted devices to help avoid disruption in device supply and help ensure an orderly and transparent transition (specific information on the scope and the timeline for the transition period can be found in each guidance).