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

What it does

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.

The Food and Drug Administration's summary, as published in the Federal Register.

What it would change

1 part of Title 21 of the Code of Federal Regulations:

21 CFR 876

What happens next and when

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.

The agency's dates, word for word.

Check it yourself

• The document in the Federal Register
• Docket FDA-2026-N-8249 on Regulations.gov
• Title 21 on eCFR

The record as published

Source: the Federal Register (public domain). The document in the Federal Register