All topics · gastroenterology-urology-devices
topicgastroenterology-urology-devices
Federal Register documents tagged gastroenterology-urology-devices. Each entry is scored 1-5 for compliance materiality and dated for any comment or effective-date deadlines.
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§ 01 Agencies issuing on this topic
§ 02 Recent documents
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Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation
Action: Ensure orally ingested transient constipation devices meet class II special controls as of 2026-06-01.
FDA classifies orally ingested transient devices for constipation as class II gastroenterology-urology devices subject to special controls. The rule codifies the device type and applicable controls, creating a 510(k)-type regulatory pathway rather than requiring the highest-risk classification.
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