Immunology and Microbiology Devices; Revocation of the Exemption From Premarket Notification; Blood Culturing System Devices

The Food and Drug Administration (FDA) is revising the microbial growth monitor classification regulation by revoking the exemption from the premarket notification requirements for automated blood culturing system devices used in testing blood and other normally sterile body fluids for bacteria, fungi, and other microorganisms. Revocation of the exemption is necessary because of the importance of these devices in providing rapid diagnosis of potentially life- threatening conditions. Devices using traditional manual methods employing turbidity measurements or direct counts, included under this classification regulation, will continue to be exempt from the requirement of premarket notification.