Alert detail
Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring
What changed
Final Rule published 2026-06-01. The Food and Drug Administration (FDA) is classifying the rigid sterilization container with electronic monitoring into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the rigid sterilization container with electronic monitoring. We are taking this action because we have det
Who’s affected: Multi-specialty billing teams · Effective: June 1, 2026
Primary source: View the official CMS/MAC document ↗
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