Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
Health and Human Services Department; Food and Drug Administration: proposed rule. Dated 80 days ago, it serves as a historical benchmark. Score 20/100. As of 2026-11-04, from Federal Register API (Office of the Federal Register).
Data as of · Compiled by Zalwin from Federal Register API (Office of the Federal Register)
Free preview: all 9 published fields of this record are shown below. Locked: 62 related FederalRegisterCompliancePulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Agency | Health and Human Services Department; Food and Drug Administration |
| Type | Proposed rule |
| Action | Proposed amendment; proposed order; request for comments. |
| Published | 2026-08-17 |
| Comments close | 2026-10-16 |
| Significant | No |
| CFR parts | 21 CFR 876 |
| 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. |
| Document number | 2026-16728 |
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- Source agency: Federal Register API (Office of the Federal Register)
- Record date: 2026-08-17
- Data refreshed: 2026-11-04
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LIVE PUBLIC DATA Source: Federal Register API (Office of the Federal Register) · Last refreshed: Wed, 04 Nov 2026 21:40:49 GMT
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Peer benchmark and outreach value: Health and Human Services Department; Food and Drug Administration and 63 food-and-drug-administration peers
- food-and-drug-administration FederalRegisterCompliancePulse records like this one: 63
- Timing: Low: older than 30 days
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20 / 100 Action Urgency Score
What is the FederalRegisterCompliancePulse record for Health and Human Services Department; Food and Drug Administration?
Health and Human Services Department; Food and Drug Administration published a proposed rule on 2026-08-17, comments due 2026-10-16: Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer.
How does Health and Human Services Department; Food and Drug Administration compare to other FederalRegisterCompliancePulse records?
It is 80 days old; check the official source for later updates before acting. Its Action Urgency Score of 20/100 is modest; treat it as background rather than a priority.
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