Federal Register #2026-10894

FDA Classifies Oropharyngeal Electrical Stimulator and Orally Ingested Device for Constipation as Class II Medical Devices

The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued final regulatory classifications for two medical devices: - Oropharyngeal electrical stimulator (Class II medical device) - Intended to treat swallowing dysfunction; may include a feeding tube - Subject to special controls: non-clinical performance testing, biocompatibility, sterility, software verification and validation, electrical safety, electromagnetic compatibility, usability testing, training, and specific labeling (including shelf life) - Orally ingested transient device for constipation (Class II medical device) - Designed to treat constipation - Subject to special controls and premarket notification requirements - No specific products, part numbers (except 874.5950 for the oropharyngeal stimulator), or purchase quantities are requested - These actions are regulatory classifications, not procurement solicitations - FDA is the only OEM or vendor mentioned - The classifications are intended to ensure safety and effectiveness while reducing regulatory burdens and enhancing patient access to innovative devices

Description

The Food and Drug Administration (FDA) is classifying the oropharyngeal electrical stimulator into class II (special controls). This device stimulates afferent nerve fibers of oropharyngeal mucosa and is intended to treat swallowing dysfunction. The classification includes special controls such as non-clinical performance testing, biocompatibility, sterility, software validation, electrical safety, usability testing, training, and labeling requirements. This action aims to provide reasonable assurance of safety and effectiveness while enhancing patient access to innovative devices by reducing regulatory burdens.

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