FDA Proposes Reclassifying Blue Light Cystoscopy Systems

On August 14, 2026, the U.S. United States — Food and Drug Administration (FDA) published a proposed order in the Federal Register to reclassify cystoscopic systems intended as an aid for the detection of bladder cancer from Class III to Class II. The FDA initiated this reclassification on its own initiative after reviewing scientific, clinical, and post-market evidence, concluding that special controls, along with general controls, would ensure reasonable assurance of safety and effectiveness. The proposed reclassification applies to systems used with an approved optical imaging agent for photodynamic blue light cystoscopy (BLC) as an adjunct to white light cystoscopy. If finalized, these devices would move from the premarket approval (PMA) pathway to the 510(k) pathway with special controls. Photocure, the manufacturer of Cysview, a key optical imaging agent used in BLC, welcomed the proposal, viewing it as a regulatory milestone that could expand access to BLC in the United States and foster innovation in cystoscopic equipment. The reclassification is subject to a public comment period and final FDA order.