Regulatory Deadline Board/2026-16728
Food and Drug Administration · Proposed Rule
Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
Closed 13 days ago
In plain English
FDA proposed reclassifying diagnostic endoscopic light source systems (OAY) from class III to class II with special controls and a new name tied to cystoscopy use.
Who it hits
Endoscopy device makers and companies selling light sources for urologic procedures.
- Agency
- Food and Drug Administration
- Document type
- Proposed Rule
- Published
- Aug 17, 2026
- Comments close
- Oct 16, 2026
- Status
- Closed 13 days ago
- Federal Register number
- 2026-16728
- Docket
- Docket No. FDA-2026-N-8249
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