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

**Action Urgency Score:** 20/100

| Field | Value |
|---|---|
| Agency | Health and Human Services Department; Food and Drug Administration |
| Type | Proposed rule |
| Action | Proposed amendment; proposed order; request for comments. |
| Published | 2026-08-17 |
| Comments close | 2026-10-16 |
| Significant | No |
| CFR parts | 21 CFR 876 |
| Summary | 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. |
| Document number | 2026-16728 |

## Why this score


Source: Federal Register API (Office of the Federal Register) (https://www.federalregister.gov/documents/2026/08/17/2026-16728/gastroenterology-urology-devices-reclassification-of-diagnostic-endoscopic-light-source-systems-to). Last refreshed: 2026-11-04T21:40:49.974Z.
Data from the Federal Register API; the published Federal Register document is authoritative. Informational only, not legal advice.