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Re: None

Monday, 08/24/2020 12:42:10 PM

Monday, August 24, 2020 12:42:10 PM

Post# of 54910
Content created by Assistant Secretary for Public Affairs (ASPA)
Content last reviewed on August 19, 2020


Those seeking approval or clearance of, or an emergency use authorization ("EUA") for an LDT may nonetheless voluntarily submit a premarket approval application, premarket notification or an EUA request, respectively, but are not required to do so, and FDA will adjudicate those submissions.