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 record

Publisher

Federal Register

Agency

Health and Human Services Department; Food and Drug Administration

Source

Federal Register

Kind

Federal Register: proposed rule

Jurisdiction

United States

Topics

Health

Importance

Notable, the middle of three tiers Kresmion sets by fixed rules from the source's own fields

Published (source time)

2026-08-17 (the source gives a date only)

First seen on Kresmion

2026-10-26 18:24 UTC

The original

• PDF (Federal Register)

Link not checked yet: one check due 2026-11-25 (the source published this record more than 7 days before Kresmion first saw it).

Source: Federal Register (federalregister.gov). U.S. government work, public domain.

The publisher's 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.

The publisher's words, as published.

Federal Register document

Document number

2026-16728

Document type

Proposed Rule

Status

Published