Guidance on Magnetic Resonance 510(k)

FDA has issued a guidance, Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, with a detailed description of the information to be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). The document says it is to be used in conjunction with information in other places on the content and format of a 510(k) premarket notification. “The approach outlined in this guidance document is intended to facilitate the timely review and marketing clearance of MRDDs,” FDA says.

The updated guidance reflects technological advances, agency regulatory decisions, standards updates, and legislative changes adopted by FDA since issuance of the previous version, it says.

Information in the guidance covers its scope; relevant standards; describing the device in a 510(k) premarket notification; electrical, mechanical, structural, and related system safety; clinical images; device modifications and the need for 510(k); and labeling.