Federal Register #FDA-2026-N-5198

FDA Classifies Endoscopic Light-Projecting Measuring Device and Endoscopic Traction Device as Class II Medical Devices

This FDA final order announces the classification of two medical devices into Class II (special controls): - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEMs and Vendors: - RQMIS Inc. (AccuMeasure System) - Covidien LLC (ProdiGI device) - Products/Devices Classified: - Endoscopic light-projecting measuring device - Projects light onto mucosal surfaces and uses software to measure features - Endoscopic traction device - Assists in endoscopic procedures - Notable Requirements: - Devices must comply with special controls, including: - In vivo and non-clinical performance testing - Biocompatibility evaluation - Software validation - Electrical, thermal, and mechanical safety testing - Electromagnetic compatibility testing - Validated reprocessing instructions - Specific labeling requirements - No specific procurement, purchase quantities, or part numbers provided - Action is regulatory, not a solicitation or award

Description

The Food and Drug Administration (FDA) is classifying the endoscopic light-projecting measuring device into class II (special controls). This classification provides reasonable assurance of safety and effectiveness and is expected to enhance patient access to innovative devices by reducing regulatory burdens. The device projects light on a mucosal surface and uses software to determine dimensions of observable features. Special controls include performance testing, biocompatibility, software validation, safety testing, and labeling requirements.

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