Medical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia
Assess whether covered devices meet the new FDA class II special controls.
- Effective: June 1, 2026
§ 01 Summary
FDA classifies real-time ultrasound anatomy visualization and labeling devices used for ultrasound-guided regional anesthesia as class II medical devices subject to special controls. The rule establishes the device type in the anesthesiology devices classification regulations, enabling regulation through class II controls rather than default higher-burden pathways.
§ 02 Why this matters
The rule codifies a new class II classification and identifies special controls that manufacturers of this device type must meet to provide reasonable assurance of safety and effectiveness. This changes the applicable FDA pathway and compliance criteria for this narrow category of ultrasound-assisted anesthesia software/devices.
§ 03 Topics
§ 04 Affected entities
- agency: FDA
- agency: Health and Human Services Department
- 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 32338 Title: Medical Devices; Anesthesiology Devices; Classification of the Real-Time Ultrasound Anatomy Visualization and Labeling Device for Ultrasound Guided Regional Anesthesia Abstract: The Food and Drug Administration (FDA) is classifying the real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia 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 real-time ultrasound anatomy visualization and labeling device for ultrasound guided regional anesthesia. 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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