FDA Proposed Reclassification: Cystoscopic Systems for Bladder Cancer Detection
Stay current with the FDA’s latest proposed rule to reclassify cystoscopic systems—specialized devices aiding bladder cancer detection—from class III (premarket approval) to class II (special controls). This focused course breaks down the regulatory rationale, clinical evidence, device technology, specific risks, and the new requirements. Learn what this shift means for manufacturers, clinicians, and patients, and how public participation can impact the final regulation. Ideal for those affected by the changing landscape of urology device regulation.
In this course you will learn the following:
* Explain the purpose and intent of the FDA’s proposed reclassification.
* Describe the regulatory framework for medical device classification.
* Summarize the history and rationale for reclassifying cystoscopic systems.
* Identify the risks associated with these devices and the proposed special controls to mitigate them.
* Understand the process and importance of public participation in the rulemaking.
* Recognize that the rule is not final and may change based on stakeholder input.
NOTE: Unless otherwise indicated, all course purchases are for access to the course for a period of 1-year. At the end of the one year term, the course will be set to “inactive”.
