FDA proposes reclassification of Blue Light cystoscopy systems
The U.S. Food and Drug Administration (FDA) has proposed reclassifying Blue Light cystoscopy systems from Class III to Class II. The proposal is initiated by the FDA on its own accord after reviewing available evidence.
The U.S. Food and Drug Administration (FDA) has initiated a proposed order to reclassify cystoscopic systems intended as an aid for bladder cancer detection from Class III to Class II, Photocure ASA announced Tuesday. Photocure ASA is known as "The Bladder Cancer Company."
The FDA's proposal stems from its own review of scientific, clinical, and post-market evidence. The agency stated that these systems can meet the requirements for Class II, which involves less stringent regulatory controls compared to Class III.
Reclassification from Class III, which typically requires premarket approval due to high risk, to Class II, which generally involves special controls, could streamline the regulatory pathway for these devices. This may lead to broader availability and adoption of the technology in clinical practice.
Photocure's Hexvix® photodynamic therapy, used in conjunction with Blue Light technology for bladder cancer diagnosis, already holds FDA approval. The company is monitoring the FDA's formal process regarding the proposed reclassification of the underlying cystoscopy systems.