Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation
Ensure orally ingested transient constipation devices meet class II special controls as of 2026-06-01.
- Effective: June 1, 2026 — Final classification order effective
§ 01 Summary
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.
§ 02 Why this matters
The rule places this device type in class II and makes FDA-identified special controls part of the codified classification, which manufacturers must satisfy to market the device. It changes the applicable regulatory pathway and compliance criteria for this specific constipation device category.
§ 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 32347 Title: Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation Abstract: The Food and Drug Administration (FDA) is classifying the orally ingested transient device for constipation 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 orally ingested transient device for constipation. 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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