Warning Letter Roundup & Recap – 1 December 2020
In the only device-related warning letter released by the US FDA this week, Avazo Healthcare was selling two COVID-19 antigen tests without approval, clearance or authorization from the agency.
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King & Spalding partner Kyle Sampson tells Medtech Insight that a joint US HHS/FDA notice that could exempt a plethora of medical devices from premarket review falls under a recent regulatory freeze from the Biden administration.
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