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FDA Unveils 3-Phase Approach For Bringing Products Back Under Compliance After Pandemic Enforcement Leeway

 
• By Shawn M. Schmitt

The US FDA says in a new draft guidance document that makers of a variety of devices and diagnostics that were given wide enforcement berth by the agency to use their products to respond to COVID-19 must eventually transition back to full regulatory compliance under a proposed three-phase plan.

Hand is turning a cube and changes the word 'Phase 2' to 'Phase 3'.
• Source: Alamy

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transition back to full regulatory compliance under a three-phase transition plan recommended by the agency in a new draft guidance document.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...

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