Federal regulators have proposed easing the approval pathway for imaging systems that urologists use to detect bladder tumors that ordinary white-light cystoscopy can miss. The FDA published the proposed order in the Federal Register on August 17, and comments are open through October 16.
The proposal would move these devices from Class III, the agency's highest-risk category requiring premarket approval, to Class II, which permits clearance through the 510(k) notification pathway with a set of special controls. The proposed order would also rename the device type a cystoscopic system intended as an aid for the detection of bladder cancer.
