Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
Updated 5 hours ago ()
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.
- Tags
- health IT, Proposed Rule, Health and Human Services Department, Food and Drug Administration
- Related exam domains
- CISSP 8: Software Development Security; CISM 3: Information Security Program; CISM 4: Incident Management; CISA 1: Information System Auditing Process
- Source record id
- 2026-16728
- First seen by InfoSec Signals
- Sep 23, 2026
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