The Food and Drug Administration (FDA) is proposing to reclassify diagnostic endoscopic light source systems (product code OAY), which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "Cystoscopic system intended as an aid for detection of bladder cancer," along with special controls that FDA believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.
US Federal Register - FDA Rules · August 17, 2026
Reclassification of Diagnostic Endoscopic Light Source Systems to Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
Original title: Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
FDA proposes reclassifying diagnostic endoscopic light source systems from class III to class II with special controls and a new regulatory name.
Published by US Federal Register - FDA Rules. HealthSignal links to the original document; the summary above is extracted from the source text.