Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
The Food and Drug Administration (FDA) is proposing to reclassify diagnostic endoscopic light source systems (product code OAY) from class III premarket approval into class II subject to premarket notification. The FDA is also proposing a new device classification regulation renaming these devices to 'Cystoscopic system intended as an aid for detection of bladder cancer.' Proposed special controls are intended to provide a reasonable assurance of device safety and effectiveness.
Original source: Federal Register — FDA Documents — 2026-08-17T04:00:00+00:00
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