# 2026-12445: FDA Classifies Endoscopic Traction Device as Moderate Risk 2026-12445, Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Device, is a Federal Register rule from Health and Human Services Department, Food and Drug Administration published 2026-06-22, effective 2026-06-22; PRIA reads it as touching household money (as of 2026-06-29). - Canonical: https://policyrisk.com/federal-register/2026-12445 - As of: 2026-06-29 - Plain-text twin of the page above; the HTML and this file carry the same facts. ## Facts - Document number: 2026-12445 - Title: Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Traction Device - Type: Rule - Agencies: Health and Human Services Department; Food and Drug Administration - Citation: 91 FR 36982 - Published: 2026-06-22 - Effective: 2026-06-22 - Comments close: not stated - Significant: no - Touches household money: yes - Regulation identifier numbers: none - Last updated: 2026-06-29 ## In one line FDA Classifies Endoscopic Traction Device as Moderate Risk ## Summary The FDA is officially putting the endoscopic traction device into Class II, meaning it now has special safety rules but fewer hurdles than the strictest category. This change helps make sure the device is safe and effective while making it easier for patients to get access to this cool medical tool. The new rules took effect on June 22, 2026, and could speed up innovation without extra costs for makers. ## Abstract The Food and Drug Administration (FDA) is classifying the endoscopic traction device 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 traction device. 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. ## Effects PRIA read - Device Classified into Class II: benefit, medium. The FDA officially classified the endoscopic traction device as Class II (special controls), effective June 22, 2026 (classification applicable June 13, 2022). FDA says this classification provides reasonable assurance of safety and effectiveness and will enhance patients' access by reducing regula… - Device Subject to 510(k) Premarket Notices: cost, medium. FDA states that endoscopic traction devices are subject to premarket notification requirements under section 510(k) of the FD&C Act (i.e., a 510(k) submission is required) at this time. - Special Controls Require Safety Testing: benefit, medium. The final order codifies special controls that require in vivo performance testing, non-clinical performance testing, usability assessment, sterility and biocompatibility data, shelf-life demonstration, and specific labeling (including recommended training and safe anatomical locations). - Manufacturers Must Meet Detailed Controls: cost, medium. Manufacturers must meet the codified special controls (testing for perforation, bleeding, device deployment, tensile strength, magnet strength if applicable, sterility, biocompatibility, shelf life, and labeling including recommended training and lesion size guidance) to fall within Class II and av… - De Novo Enables Predicate Use for Future Devices: benefit, medium. FDA states that because this device was classified via the De Novo process, the endoscopic traction device can serve as a predicate for future devices of that type, allowing other sponsors to use the less burdensome 510(k) process rather than a De Novo or premarket approval. - Device Is Prescription-Only: cost, low. The final order identifies the endoscopic traction device as a prescription device (prescription use only) and notes prescription devices are exempt from the requirement for adequate directions for layperson use under section 502(f)(1) of the FD&C Act, provided conditions of 21 CFR 801.109 are met. ## Related documents - [2026-16296](https://policyrisk.com/federal-register/2026-16296): Substances Generally Recognized as Safe, 2026-08-11 - [2026-14073](https://policyrisk.com/federal-register/2026-14073): Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign E…, 2026-07-13 - [2026-13047](https://policyrisk.com/federal-register/2026-13047): Establishment Registration and Product Listing for Tobacco Products, 2026-06-29 - [2025-04978](https://policyrisk.com/federal-register/2025-04978): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-03-25 - [2025-01840](https://policyrisk.com/federal-register/2025-01840): Nonprescription Drug Product With an Additional Condition for Nonprescription Use, 2025-01-27 - [2026-20727](https://policyrisk.com/federal-register/2026-20727): Medical Devices; Immunology and Microbiology Devices; Classification of the System for Detection of Nucleic Acid From Non-Viral Microorgani…, 2026-10-09 ## Sources - [2026-12445 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/22/2026-12445/medical-devices-gastroenterology-urology-devices-classification-of-the-endoscopic-traction-device) - [2026-12445 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-22/pdf/2026-12445.pdf) ## Related - [Previous: 2026-12444, Medical Devices; Gastroenterology-Urology Devices; Classification of the Endosc…](https://policyrisk.com/federal-register/2026-12444) - [Next: 2026-12448, Rescinding the Requirement for Electronic Logging Device Operator's Manual Loca…](https://policyrisk.com/federal-register/2026-12448) - [All Federal Register documents](https://policyrisk.com/federal-register) Source: PRIA, https://policyrisk.com/federal-register/2026-12445 (as of 2026-06-29).