Federal Register #Docket No. FDA-2026-N-5196

FDA Classifies Swallowable Capsule for Constipation and Sterilization Container as Class II Devices

The Food and Drug Administration (FDA), through its Center for Devices and Radiological Health, has issued a final order classifying two medical devices as Class II with special controls: - Orally ingested transient device for constipation - An electric, swallowable capsule designed to pass through the gastrointestinal tract to treat constipation - Requires clinical and non-clinical performance testing, biocompatibility evaluation, software validation, electrical safety, electromagnetic compatibility, and specific labeling (including shelf life) - Vibrant Ltd. is identified as the OEM and requester for the De Novo classification of the Vibrant System, which serves as the predicate device - Rigid sterilization container with electronic monitoring - A rigid container equipped with electronic monitoring for sterilization purposes - Also classified as Class II with special controls to ensure safety and effectiveness - Both classifications are intended to ensure device safety and effectiveness while reducing regulatory burdens and facilitating patient access to innovative devices - No procurement, solicitation, or award is announced in this notice

Description

The Food and Drug Administration (FDA) is classifying the orally ingested transient device for constipation into class II (special controls). This device is an electric swallowable capsule that naturally passes through the gastrointestinal tract for the treatment of constipation. The classification includes special controls to ensure safety and effectiveness, such as clinical data requirements, non-clinical performance testing, biocompatibility evaluation, software validation, 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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