The US Food and Drug Administration (FDA) has revised its position on magnetic resonance (MR) with updates to a pair of final guidance documents.
One of the guidance documents covers the testing and labeling of medical devices for safety in the MR environment. The other document addresses premarket notifications for magnetic resonance diagnostic devices (MRDDs). FDA originally issued guidance on MRDDs and safety in the MR environment in 2016 and 2021, respectively, and updated both documents on 10 October 2023.
Neither document has undergone an extensive revision, with most of the content unchanged from the earlier versions. FDA has made more changes to the MRDD guidance than the MR environment text, in part because of the need to update the document to reflect a new edition of the recognized standard on the basic safety and essential performance of magnetic resonance equipment for medical diagnosis…
