Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring
Verify affected devices meet the new class II special controls by 2026-06-01.
- Effective: June 1, 2026 — Rule effective on publication date.
§ 01 Summary
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.
§ 02 Why this matters
The rule creates codified special controls for a specific medical device type, which manufacturers must satisfy for class II compliance and marketing submissions. This changes the regulatory classification and compliance expectations for rigid sterilization containers with electronic monitoring.
§ 03 Topics
§ 04 Affected entities
- agency: FDA
- agency: HHS
- industry: medical-device-manufacturers
- statute: FDCA
§ 05 Matching feeds
§ 06 Source document
Read the full Federal Register entry on federalregister.gov.
Show classifier input (what GPT-5.5 saw)
Type: Rule Agencies: Health and Human Services Department; Food and Drug Administration Citation: 91 FR 32349 Title: Medical Devices; General Hospital and Personal Use Devices; Classification of the Rigid Sterilization Container With Electronic Monitoring Abstract: 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 determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Classified Jun 3, 2026 by gpt-5.5. Fetched Jun 2, 2026.
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