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Requests the FDA to take the administrative action to require that the reported malfunction, failure, or patient harm (collectively referred to hereafter as “failure”) in an FDA-regulated medical device, when said failure is directly associated with or temporally immediately following exposure to an MRI scanner, through MedWatch or MDR reporting channels,
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Citizen Petition from Tobias Gilk
Citizen Petition from Tobias Gilk
Nonrulemaking
Other
FDA-2025-P-3439-0001
Biomedical Research
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The document's own metadata, straight from regulations.gov.
Posted
Sep 4, 2025
Agency
Food and Drug Administration (FDA)
