FDA Draft Guidance for Medical Devices Prepares for End of Pandemic
Highlights
The FDA has issued two separate draft guidance documents for medical devices being marketed subject to 1) an Emergency Use Authorization and 2) enforcement discretion
Both guidance documents propose transition plans of at least 180 days; public comments are being accepted until March 23, 2022
Different types of devices will be treated differently, so manufacturers should consider carefully reviewing the guidance documents
The FDA’s Center for Devices and Radiological Health (CDRH) has published two draft guidance documents in anticipation of the end of the public health emergency brought about by the COVID-19 pandemic. One addresses the transition plan for medical devices being marketed under an Emergency Use Authorization (EUA) and the other describes the transition plan for medical devices on the market subject to enforcement discretion.
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