Opportunity
Federal Register #FDA-2026-N-8249
FDA Reclassification and Regulation Proposal for Cystoscopic Systems in Bladder Cancer Detection
Buyer
Food and Drug Administration
Posted
August 17, 2026
Respond By
October 16, 2026
Identifier
FDA-2026-N-8249
NAICS
339112, 334510, 339113
This opportunity concerns the FDA's proposed reclassification and new regulation for medical devices used in bladder cancer detection. - Government Buyer: - Food and Drug Administration (FDA) - Center for Devices and Radiological Health - Products/Services Requested: - Diagnostic endoscopic light source systems (product code OAY) - Cystoscopic systems intended as an aid for detection of bladder cancer - Includes cystoscope and accessories used with approved optical imaging agents (e.g., CYSVIEW) - OEMs and Vendors: - No specific OEMs or vendors are named in the notice - Unique/Notable Requirements: - Devices will be reclassified from class III to class II, subject to special controls - Special controls include: - Clinical and non-clinical testing - Electrical, mechanical, thermal, and optical safety testing - Software verification and validation - Electromagnetic compatibility testing - Sterilization/reprocessing validation - Shelf-life testing - Biocompatibility evaluation - Labeling requirements - Devices are prescription-only and require FDA clearance (premarket notification under section 510(k)) - Not intended as the sole or definitive basis for diagnosis; must be used as an adjunct to white light cystoscopy - Safety measures to mitigate risks such as false positives/negatives, device malfunction, and infection
Description
The Food and Drug Administration (FDA) proposes to reclassify diagnostic endoscopic light source systems, which are currently class III devices, into class II with special controls, subject to premarket notification. FDA also proposes a new device classification regulation named "Cystoscopic system intended as an aid for detection of bladder cancer" to ensure safety and effectiveness. The reclassification aims to provide reasonable assurance of safety and effectiveness through special controls. Comments on the proposed order must be submitted by October 16, 2026.