FDA classifies endoscopic light-projecting measuring device as Class II
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The Food and Drug Administration has officially classified a specific type of medical tool called the “endoscopic light-projecting measuring device” into Class II. This classification applies to devices that project light onto internal tissue surfaces and use software to measure the size of visible features, such as polyps or lesions.
Why it matters: This action is primarily administrative but has practical implications for medical device manufacturers. Moving a device from Class III to Class II allows companies to bring similar tools to market faster through the less burdensome 510(k) notification process rather than full premarket approval. It also establishes this device type as a “predicate,” meaning future manufacturers of substantially equivalent devices can use it as a benchmark for their own safety reviews.
Who it affects
- Manufacturers and developers of endoscopic measuring tools
This final order was issued by the Food and Drug Administration under the Department of Health and Human Services; readers should consult the original Federal Register document for full regulatory text and compliance details.
Agency: Health and Human Services Department, Food and Drug Administration
Source: Federal Register — read the official document