Benchmark: FDA Proposed Reclassification: Cystoscopic Systems for Bladder Cancer Detection
Take this benchmark to assess how much you would benefit from taking the course on FDA’s proposed reclassification of cystoscopic systems intended as an aid for detection of bladder cancer.
This quick, 10-question check helps you gauge your grasp of why the reclassification matters, who it affects, and what could change in practice if these devices move from class III (PMA) to class II (special controls).
- See the why: Clarify FDA’s intent, the evidence behind the shift, and the trade-offs (speed to market vs. safeguards, sensitivity vs. specificity).
- Anticipate impact: Understand how special controls shape testing, labeling, software, and reprocessing—and what that means for patients, clinicians, and manufacturers.
- Act with confidence: Spot where your organization may need training, new documentation, or workflow updates, and how to engage through public comments.
Results will highlight areas where the full course can deepen your understanding—so you can make better regulatory, clinical, and product decisions before the rule is finalized.
NOTE: Unless otherwise indicated, all Benchmarks are free of charge!
