Stay ahead of regulatory changes impacting breast cancer screening technologies with this targeted course on the FDA’s proposed reclassification of digital breast tomosynthesis (DBT) systems. Learn about the transition from class III (premarket approval) to class II (special controls), the rationale behind the proposed rule, and the impact on device manufacturers, healthcare professionals, and patients. The course provides a detailed look at required special controls, device risks, regulatory background, and the public comment process, equipping you to respond effectively to forthcoming regulatory requirements.
In this course you will learn the following:
* Understand the purpose and intent of the proposed reclassification of DBT systems.
* Describe the regulatory framework for medical device classification.
* Identify the risks associated with DBT systems and the proposed special controls to mitigate them.
* Recognize the process for submitting public comments and the importance of stakeholder participation.
* Explain how the proposed rule may evolve based on feedback and is not yet final.
