Medical Devices; Gastroenterology-Urology Devices; Classification of the Orally Ingested Transient Device for Constipation
Key claim: The FDA is classifying the orally ingested transient device for constipation as a Class II medical device subject to special controls, determining this provides reasonable assurance of safety and effectiveness while reducing regulatory burdens.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) 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.
Why this matters
Class II classification with special controls establishes a defined regulatory pathway for orally ingested transient devices treating constipation, letting future manufacturers pursue 510(k) clearance rather than the more burdensome premarket approval route. For patients, this can broaden access to non-pharmacologic constipation treatment options as more devices in this category reach market.