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Re: Vanilla Fitbit post# 20431

Monday, 09/14/2020 12:22:30 PM

Monday, September 14, 2020 12:22:30 PM

Post# of 44695
Wilma ..theres more to it than "may be effective "

FDA guidance

For FDA to issue an EUA, there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition. A potential alternative product may be considered “unavailable” if there are insufficient supplies of the approved alternative to fully meet the emergency need.



Kiwi