FDA Warning Letter Recap, May 2021: More COVID-19 Diagnostics Enforcement
The US FDA released two warning letters in May related to the sale of unapproved COVID-19 tests.
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For five years Owlet Baby Care Inc. has said its Smart Sock monitoring product isn’t a medical device. But the US FDA disagreed – and finally put its foot down in a warning letter that told the company to come into compliance or stop selling the sock. So Owlet decided to do both.