$49.99
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.
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”.
Why This Course is Important
Without this course, you may miss critical regulatory updates that affect compliance, risk management, and your ability to contribute informed feedback during the public comment period. Stay ahead on safety standards and new device requirements.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Microbiology Devices; Reclassification of Mycobacterium Tuberculosis Cell-Mediated Immunity Tests and Immune Response Enzyme-Linked Immunospot Tests.
Key regulatory references include:
Course SKU
FR-26-1828-1
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Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update. Document Number: 2026-06675
Buy this Course
FR-26-1848-1
Why This Course is Important
Without this course, you may miss important details on payment updates, new reporting requirements, and potential financial and compliance impacts for inpatient psychiatric facilities under Medicare in FY 2027.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medicare Program; FY 2027 Inpatient Psychiatric Facilities Prospective Payment System-Rate Update.
Key regulatory references include:
Course SKU
FR-26-1848-1
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