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# Guide on Magnetic Resonance Diagnostics
- URL: https://www.fdaweb.com/guide-on-magnetic-resonance-diagnostics/
- Published: 2023-10-10T12:00:00.000Z
- Updated: 2026-09-14T19:01:30.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155529

FDA has released a [final guidance](https://www.fda.gov/media/92921/download?ref=fdaweb.com) entitled “Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices.” The document is intended to harmonize with the 4th 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.

FDA notes that in the fourth 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.” Earlier versions of the standard defined this controlled access area as 0.5 mT, it says.