FDA releases guidance for passive device safety with MR
Device Regulation Alert: Safety, Compliance and Reimbursement News, August 25, 2008
Manufacturers of passive implants should provide non-clinical testing information premarket approval, investigational device exemption, or 510(k) applications to establish the safety and compatibility of the implant in the magnetic resonance (MR) environment, according to new FDA guidance.
- Test objective
- Equipment used
- Acceptance criteria
- Number of devices tested
- Description of devices tested, including device size
- Results (summarized and raw form)
Patients with implanted devices have been killed or burned while undergoing MR scans. Implanted devices can also affect the quality of the scan, rendering the scan unusable or leading to an improper diagnosis.
Active implants or devices that are not implants are not included in the guidance.
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