Alerts3.16.22
FDA Draft Guidance for Medical Devices Prepares for End of Pandemic
The FDA has issued two separate draft guidance documents for medical devices being marketed subject to 1) an Emergency Use Authorization and 2) enforcement discretion
The FDA’s Center for Devices and Radiological Health (CDRH) has published two draft guidance documents in anticipation of the end of the public health emergency brought about by the COVID-19 pandemic.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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