# 2026-12444: Endoscopic Measuring Device Gets Class II FDA Status

2026-12444, Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring 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/2026-12444
- As of: 2026-06-29
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2026-12444
- Title: Medical Devices; Gastroenterology-Urology Devices; Classification of the Endoscopic Light-Projecting Measuring Device
- Type: Rule
- Agencies: Health and Human Services Department; Food and Drug Administration
- Citation: 91 FR 36980
- 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

Endoscopic Measuring Device Gets Class II FDA Status

## 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.

## Abstract

The Food and Drug Administration (FDA) is classifying the endoscopic light-projecting measuring 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 light-projecting measuring 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

- Class II status allows predicate use: benefit, medium. 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 approv…
- 510(k) premarket notification required: cost, medium. 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: cost, medium. 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/mechan…
- FDA says patient access may improve: benefit, low. 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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## Sources
- [2026-12444 on federalregister.gov](https://www.federalregister.gov/documents/2026/06/22/2026-12444/medical-devices-gastroenterology-urology-devices-classification-of-the-endoscopic-light-projecting)
- [2026-12444 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2026-06-22/pdf/2026-12444.pdf)

## Related
- [Previous: 2026-12443, Medical Devices; Immunology and Microbiology Devices; Classification of the Sim…](https://policyrisk.com/federal-register/2026-12443)
- [Next: 2026-12445, Medical Devices; Gastroenterology-Urology Devices; Classification of the Endosc…](https://policyrisk.com/federal-register/2026-12445)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2026-12444 (as of 2026-06-29).