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Open for comment Health and Human Services Department, Food and Drug Administration Docket Docket No. FDA-2026-N-8249

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

💬 Comments close in 59 days (Oct 16)

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Timeline

  1. Proposed / opened

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

  2. Related document

    Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer

Briefs in this proceeding

FYI FDA 💬 Comments close in 59 days (Oct 16)

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...

Sources

Health and Human Services Department, Food and Drug Administration · Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer · Aug 17