Nonrulemaking

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,

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
OtherSep 4, 2025
Citizen Petition from Tobias Gilk
No comment period💬 19 comments
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