Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator
Review class II special controls before marketing oropharyngeal electrical stimulators.
- Effective: June 1, 2026
§ 01 Summary
FDA classifies oropharyngeal electrical stimulators used in ear, nose, and throat applications as class II medical devices subject to special controls. The rule codifies the device type and applicable controls, creating a defined regulatory pathway for future marketing of these devices.
§ 02 Why this matters
The rule codifies class II classification and special controls for oropharyngeal electrical stimulators, so manufacturers marketing this device type must address those controls as part of FDA compliance and premarket strategy.
§ 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 32345 Title: Medical Devices; Ear, Nose, and Throat Devices; Classification of the Oropharyngeal Electrical Stimulator Abstract: The Food and Drug Administration (FDA) is classifying the oropharyngeal electrical stimulator 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 oropharyngeal electrical stimulator. 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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