Federal Register #2026-10908

FDA Classifies Rigid Sterilization Container with Electronic Monitoring as Class II Medical Device

The Food and Drug Administration (FDA) has issued a final rule regarding the classification of a new medical device: - The device: Rigid sterilization container with electronic monitoring - Intended to enclose medical devices for sterilization by healthcare providers - Maintains sterility until use and provides real-time electronic monitoring of sterility status - Classification details: - Device is now classified as a Class II medical device with special controls - Special controls include: - Non-clinical performance testing - Biocompatibility evaluation - Software validation - Human factors testing - Electromagnetic compatibility and electrical safety testing - Specific labeling requirements - Regulatory impact: - Designed to ensure safety and effectiveness - Reduces regulatory burdens for manufacturers - Facilitates patient access to innovative devices - OEM and sponsor: - Zuno Medical, Inc. is referenced as the device sponsor for the Zuno Smart Sterilization Container - No specific procurement or purchase quantities are listed, as this is a device classification rule, not a solicitation

Description

The Food and Drug Administration (FDA) is classifying the rigid sterilization container with electronic monitoring into class II (special controls). This device is intended to enclose medical devices for sterilization by a health care provider, maintain sterility until use, and provide real-time electronic monitoring of sterility status. The classification aims to provide reasonable assurance of safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices. Special controls include non-clinical performance testing, biocompatibility evaluation, software validation, human factors testing, and specific labeling requirements.

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