FDA Classifies Endoscopic Traction Device as Moderate Risk
Published Date: 6/22/2026
Rule
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.
Analyzed Economic Effects
6 provisions identified: 3 benefits, 3 costs, 0 mixed.
Device Classified into Class II
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 regulatory burdens.
Device Subject to 510(k) Premarket Notices
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
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
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 avoid automatic Class III assignment.
De Novo Enables Predicate Use for Future Devices
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
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.
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