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Zdrowie i gospodarka · 06/03/2019

FDA Proposes Exemption for Certain Flow Cytometer Instruments from Premarket Notification Requirements

The FDA is seeking public comments on a proposed exemption for certain flow cytometer instruments from premarket notification requirements, which would allow these devices to be marketed without prior FDA approval, subject to specific conditions and limitations.

Source: Federal Register — Food and Drug AdministrationOpen original release →