Zdrowie i gospodarka · 23.12.2021

Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 Public Health Emergency; Draft Guidance for Industry and Food and Drug Administration Staff; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of the draft guidance entitled "Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency." FDA recognizes that it will take time for device manufacturers, healthcare facilities, healthcare providers, patients, consumers, and FDA to adjust from policies adopted and operations implemented during the declared public health emergency (PHE) to normal operations. To provide a clear policy for all stakeholders and FDA staff, the Agency is issuing this guidance to describe FDA's general recommendations for a phased transition process with respect to devices that fall within enforcement policies issued during the COVID-19 PHE, including recommendations regarding submitting a marketing submission, as applicable, and taking other actions with respect to these devices. FDA is concurrently issuing a companion guidance to describe FDA's recommendations for this transition process with respect to devices issued Emergency Use Authorizations (EUAs) during the COVID-19 PHE. This draft guidance is not final nor is it in eff