The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.'' This draft guidance provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). This draft guidance is not final nor is it in effect at this time.
Document
Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devi...
Legal Citation
Federal Register Citation
Use this for formal legal and research references to the published document.
80 FR 41046
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability,” thefederalregister.org (July 14, 2015), https://thefederalregister.org/documents/2015-17250/submission-of-premarket-notifications-for-magnetic-resonance-diagnostic-devices-draft-guidance-for-industry-and-food-and.