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Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices....

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.'' This guidance provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD).

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81 FR 81783

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“Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Guidance for Industry and Food and Drug Administration Staff; Availability,” thefederalregister.org (November 18, 2016), https://thefederalregister.org/documents/2016-27842/submission-of-premarket-notifications-for-magnetic-resonance-diagnostic-devices-guidance-for-industry-and-food-and-drug-.