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,
🏛 Food and Drug Administration (FDA)FDA-2025-P-3439
Documents
1
Total comments
19
all analyzed
Comment status
Open
Last activity
Jul 11, 2026
In this docket
Documents
Rules, notices, and supporting material — the primary rule pinned first.
📄 Primary document
