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Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
Read on FederalRegister.gov · Official PDF · Docket on Regulations.gov · Add to calendar (.ics)
Summary (from the Federal Register abstract)
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 type
- Proposed Rule
- Federal Register document number
- 2026-16728
- Published
- Aug 17, 2026
- Action
- Proposed amendment; proposed order; request for comments.
- Docket
- FDA-2026-N-8249
- Comments posted on Regulations.gov (at last check)
- 4
- CFR parts
- 21 CFR 876
- DATES section (from the document)
- 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.
- Topics (auto-tagged)
- Medical devices
Source: Federal Register API, document 2026-16728. Federal Register text is a U.S. government work. Confirm dates in the official document; later documents may extend, reopen or correct them.