Data / Federal rules / 2026-16728
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 published this proposed rule in the Federal Register on August 17, 2026. Comments closed on October 16, 2026.
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What the agency says
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.
Key facts
- Document number
- 2026-16728
- Type
- Proposed rule
- Action
- Proposed amendment; proposed order; request for comments
- Agency
- Health and Human Services Department; Food and Drug Administration
- Published
- August 17, 2026
- Comments due
- October 16, 2026
- Dates
- Either electronic or written comments on the proposed order must be submitted by October 16, 2026. Please see Section X of this document for the proposed effective date when the new requirements would apply and for the proposed effective date of a final order based on this proposed order.
- Docket
- Docket No. FDA-2026-N-8249
- Code of Federal Regulations
- 21 CFR 876
- Topics
- Medical devices
- Pages
- 9
Other documents from the Food and Drug Administration
Everything from the Food and Drug Administration · Rules on medical devices · Published in August 2026
Read from the Federal Register API, last updated 2026-10-23. The document on federalregister.gov is the official record; dates and dockets can change through later corrections. Free to reuse with credit to SpecStream under CC BY 4.0.