Two Final Guides on Covid-19 Device Transition

FDA has issued two final guidances on transition plans for Covid-19-related medical devices that were granted emergency use authorizations or were allowed to be marketed under the agency’s enforcement discretion policy. The guidances outline the agency’s general recommendations to transition from policies/operations implemented during the Covid-19 pandemic, including:

• Developing a transition implementation plan,
• Submitting a marketing submission, and
• Taking other actions with respect to the devices.

FDA says there will be a 180-day transition period for affected devices to help prevent device supply issues and help ensure an orderly and transparent transition.

The guidance can be viewed below:

• 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