Alert detail
Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation
Policy ID: 2026-10904Specialty: Multi-specialtyAdded: 6/2/2026Effective: 2026-06-01federal rule
What changed
Final Rule published 2026-06-01. 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 c
Who’s affected: Multi-specialty billing teams · Effective: 2026-06-01
Primary source: View the official CMS/MAC document ↗
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