Petition asks FDA to implement new OEM rule for MRI safety

Should OEMs provide more information about the radiofrequency (RF) field distribution of their MRI scanners? Certified MR Safety Officer Tobias Gilk says yes.

Near-field focal heating risks have prompted Gilk to file a citizen's petition to the U.S. Food and Drug Administration (FDA) asking the agency to implement a new MRI safety rule. Gilk wants OEMs to be required to provide RF spatial distribution information for the whole patient-accessible volume in a manner consistent with the ways in which MRI system manufacturers routinely provide information on the static magnetic field (B0) and spatial field gradient (SFG).

Specifically, the petition (FDA-2026-P-6403-0001) posted June 5, 2026, asks the FDA to:

1. Direct an administrative action requiring minimum national RF safety standards for MRI devices, so users better understand and can manage (or eliminate) near-field RF burn risks.
2. Communicate this administrative change to FDA staff, industry, and the public.
3. For future-approved MRI devices, require operator manuals to include maps/diagrams showing unloaded RF body coil energy intensity across the entire patient-accessible volume -- similar to existing B0 and SFG maps; and require MR system designs to prevent near-field RF burns.

Disclosing RF spatial distribution information would be less costly and time-consuming than re-engineering the integrated RF body coil position relative to the bore wall, suggested Gilk in his petition. He also highlighted a gap in International Electrotechnical Commission (IEC) standards, saying that complying with IEC 60601-2-33 minimum disclosures means that MRI vendors are not required to provide spatial distribution information of the RF field for the full patient-accessible volume.

MR Safety Officer Tobias Gilk

"This petition would not ask the FDA to stop using IEC standards, but rather to recognize that the near-field focal heating risk, the most frequent etiology of the most frequent form of MRI patient injury catalogued by [medical device reporting] MDR, is not presently managed by the minimum requirements of IEC 60601-2-33," the document states. Gilk told AuntMinnie that the same request was made within IEC. 

The length of the RF coil that does the transmitting is a piece of the answer, Gilk told AuntMinnie. "But without location and intensity information, simply knowing that an integrated RF-transmitting body coil is 55 cm long, alone, doesn’t really help MRI providers better understand the nature of the risk that they’re supposed to manage."

According to Gilk, some MRI manufacturers are now identifying their provided RF spatial distribution information as being particular to occupational exposure as required by the EU. There is international precedent for specific national or multi-national requirements for additional information, and RF field map provision called for is information readily available, he noted.

"MRI technologists and radiologists would take this near-field risk much more seriously (and would be more consistent about applying the known protections) if the OEMs would simply show us where and how powerful the RF energies are," Gilk told AuntMinnie via email. 

A commenter identified on regulations.gov as MRI technologist and MR Safety Officer (MRSO) Mareena Cooley wrote that access to the information could provide front-line MRI professionals with another valuable tool when evaluating complex or nonstandard circumstances, including assessing potential heating risks associated with abandoned leads and potential injury risks related to retained metallic foreign bodies.

"Providing qualified MRI safety professionals with greater access to RF field distribution information would increase transparency, support evidence-based risk assessment, and further promote patient safety," the commenter added.

Gilk hopes that more people will come forward to support better disclosure of exactly where the RF risks live within the MRI bore. 

"[Response has] been a mixed bag, so far, with some enthusiastically supporting the idea, others who were convinced that 'surely this information is already shared,' and some who generally take a dim view of government regulation," Gilk told AuntMinnie.