FDA proposes 510(k) exemption for certain flow cytometers

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April 2019—The U.S. Food and Drug Administration is issuing a proposed order to exempt certain class II flow cytometry instruments from premarket notification (510[k]) requirements, subject to limitations and conditions. The FDA will continue to review the relevant functionality of these devices when they are used clinically with an in vitro diagnostic device reagent or test kit that is subject to FDA premarket review.