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Federal Register documents tagged hospital-sterilization-equipment. Each entry is scored 1-5 for compliance materiality and dated for any comment or effective-date deadlines.
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§ 01 Agencies issuing on this topic
§ 02 Recent documents
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Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring
Action: Verify affected devices meet the new class II special controls by 2026-06-01.
FDA classifies rigid sterilization containers with electronic monitoring as class II medical devices subject to special controls. The rule codifies device-specific controls intended to provide reasonable assurance of safety and effectiveness and establishes the regulatory pathway for this device type.
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