Stay current with the FDA’s proposed reclassification of Mycobacterium tuberculosis (TB) diagnostic devices. This course outlines the regulatory shift from class III to class II, introducing special controls to improve safety and effectiveness. Learn about key risks—including misinterpretation of results and operational errors—and discover how new standards, labeling requirements, and public participation will shape the future of TB diagnostics. Ideal for professionals responsible for compliance, laboratory operations, and device development.
In this course you will learn the following:
* Understand the purpose and intent of the proposed rule on Mycobacterium tuberculosis.
* Identify the key risks associated with TB diagnostic devices and the proposed mitigation strategies.
* Navigate the process for submitting public comments and participating in the rulemaking process.
* Recognize that the rule is not final and may change based on stakeholder feedback.
