This guidance document provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). This document is intended to be used in conjunction with information regarding 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.


The guidance reflects an update to harmonize with the 4 th edition of the FDA recognized standard IEC 60601-2-33 Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis. In the 4th edition of IEC 60601-2-33, the main magnetic field (B0) hazard area was re-defined as anywhere where the magnetic field is equal to or greater than 0.9 mT as the space around MR equipment where the static magnetic field can cause harm. Prior versions of IEC 60601-2-33 had defined this controlled access area as 0.5 mT. For the current edition of the FDA-recognized consensus standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database


If submitting a Declaration of Conformity to a recognized standard, we recommend you include the appropriate supporting documentation. For more information regarding use of consensus standards in regulatory submissions, refer to the FDA guidance titled “Appropriate Use of Voluntary Consensus
Standards in Premarket Submissions for Medical Devices.”