Alert detail
Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation
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: June 1, 2026
Primary source: View the official CMS/MAC document ↗
Get the action steps and full analysis
The full analysis, the revision comparison and the as-of-date version of this policy are what a partner packet carries. The source document above is free and always will be.