Makers of a variety of devices and diagnostics that were given enforcement leeway by the US Food and Drug Administration to use their products to respond to COVID-19 must eventually transition back to full regulatory compliance under a three-phase transition plan recommended by the agency in a new draft guidance document.
Published in the Federal Register on 23 December, the 24-page “Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the COVID-19 Public Health Emergency” is a companion doc to another draft guidance released by the agency on 22 December. That separate draft explains how manufacturers of emergency use authorized (EUA) devices can transition those products to full marketing clearance or approval. (See