CDRH Industry: Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices - Draft Guidance for Industry and FDA Staff

A draft guidance document has been posted titled, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices."  This draft guidance provides the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). This document is a recommendation of how to comply with certain requirements contained in 21 CFR 807.87 and is intended to be used in conjunction with information regarding the content and format of a 510(k) premarket notification.