Endoscopic Measuring Device Gets Class II FDA Status
Published Date: 6/22/2026
Rule
Summary
The FDA is officially putting the endoscopic light-projecting measuring 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 speeding up patient access to cool new tech. The new rules took effect June 22, 2026, and could save time and money for makers and users alike.
Analyzed Economic Effects
4 provisions identified: 2 benefits, 2 costs, 0 mixed.
Class II status allows predicate use
The FDA classified the endoscopic light-projecting measuring device as Class II (special controls). Because of this classification, the device can serve as a predicate for future devices, allowing other device sponsors to use the less burdensome 510(k) process instead of De Novo or premarket approval.
510(k) premarket notification required
FDA states that endoscopic light-projecting measuring devices are subject to premarket notification under section 510(k). If you make this device, you must submit a 510(k) premarket notification to FDA before marketing the device unless FDA later exempts the device type.
New testing and labeling special controls
The final order lists special controls manufacturers must meet, including in vivo performance testing, non-clinical performance testing (accuracy, endoscope compatibility, battery life, durability, light safety), biocompatibility, software verification and hazard analysis, electrical/thermal/mechanical safety testing, electromagnetic compatibility testing, validated reprocessing methods, and specific labeling requirements (accuracy, compatibility, light hazard warnings, validated reprocessing instructions). These controls are codified at 21 CFR 876.1530 and apply as of June 22, 2026.
FDA says patient access may improve
FDA states that classifying this device into Class II will enhance patients' access to beneficial innovative devices by reducing regulatory burdens. The final order intends to provide reasonable assurance of safety and effectiveness while helping speed patient access to the technology.
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