Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Suturing Device for Altering Gastric Anatomy for Weight Loss
Key claim: The FDA is classifying the endoscopic suturing device for altering gastric anatomy for weight loss into Class II (special controls), determining this provides reasonable assurance of safety and effectiveness while enhancing patient access.
Abstract
(Rule · Health and Human Services Department, Food and Drug Administration) The Food and Drug Administration (FDA) is classifying the endoscopic suturing device for altering gastric anatomy for weight loss 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 endoscopic suturing device for altering gastric anatomy for weight loss. 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
Classifying endoscopic gastric suturing devices as Class II establishes a 510(k) pathway for less-invasive weight-loss procedures, potentially expanding provider access to endoscopic bariatric alternatives to surgery. For patients, this may broaden the range of covered weight-loss interventions as manufacturers can more readily bring competing devices to market under the special controls framework.