The proposed reclassification affects systems used alongside optical imaging agents to detect bladder cancer, including carcinoma in situ. By moving these devices from the stringent premarket approval pathway to the 510(k) process, the FDA aims to establish special controls that reflect the mature clinical status of the technology. The agency noted that its decision was based on a lack of significant post-market safety signals and extensive historical data regarding the efficacy of blue light cystoscopy.
FDA Proposes Downgrading Bladder Cancer Imaging to Class II
The U.S. Food and Drug Administration has initiated a process to reclassify blue light cystoscopy systems from Class III to Class II, marking a significant regulatory shift for the industry. This move follows the agency’s internal review of clinical evidence, which affirmed the safety and effectiveness of the diagnostic technology.
Dan Schneider, CEO of Photocure, described the move as a vital milestone that aligns regulatory oversight with the real-world application of their diagnostic tools. The transition is expected to lower barriers for hospitals to adopt the technology, potentially fostering innovation in equipment platforms. While the proposal remains subject to a public comment period, the company anticipates that the shift will serve as a catalyst for expanding access to precision diagnostics for patients across the United States.
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