FYI FDA

FDA Proposes Downgrading Bladder Cancer Detection Endoscopes from Class III to Class II

FDA seeks to reclassify diagnostic endoscopic light source systems for bladder cancer detection to Class II with special controls, eliminating premarket approval requirements. The FDA is proposing to reclassify diagnostic endoscopic light source systems (product code OAY) from Class III...

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Corrected · August 18, 2026