FDA proposes reclassifying blue light cystoscopy systems to Class II

Regulation
โดย PR Newswire·US·Read original
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Photocure ASA announced that the U.S. Food and Drug Administration has published a proposed order to reclassify cystoscopic systems used for detecting bladder cancer from Class III to Class II. The FDA initiated the reclassification on its own initiative after reviewing scientific, clinical, and post-market evidence, concluding that special controls can ensure safety and effectiveness. The proposal applies to systems used with an approved optical imaging agent for photodynamic blue light cystoscopy as an adjunct to white light cystoscopy. Photocure's President and CEO Dan Schneider called the move a very important regulatory milestone that will serve as a tremendous catalyst for the U.S. business. If finalized, the reclassification would move applicable systems from the premarket approval pathway to the 510(k) pathway with special controls, and Photocure believes it will facilitate innovation and expand access to blue light cystoscopy with Cysview.

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FDA proposes reclassifying blue light cystoscopy systems to Class II, a regulatory milestone for Photocure's Cysview.

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