$49.99
Explore the FDA’s proposed reclassification of hepatitis B virus (HBV) assay devices, transitioning from class III to class II status. This course covers the regulatory background, the proposed changes, and the implications for manufacturers, healthcare providers, and other stakeholders. Learn about the introduction of special controls and how they ensure device safety and effectiveness. Understand the new opportunities this reclassification presents for market access and innovation.
In this course you will learn the following:
* Understand the purpose and intent of the proposed reclassification.
* Recognize the importance of public participation and how to submit comments.
* Identify potential changes and the impact of the reclassification on device regulation.
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, participants may lack crucial insights into the regulatory changes affecting HBV assay devices, potentially missing out on new market opportunities and understanding the implications for clinical practice.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices.
Key regulatory references include:
Course SKU
FR-24-212-1
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Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program; Correction. Document Number: 2026-04797
Buy this Course
FR-26-1798-1
Why This Course is Important
Without this course, you risk missed reimbursement opportunities, non-compliance penalties, and operational setbacks as new Medicare regulations take effect in 2028.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medicare and Medicaid Programs; CY 2026 Payment Policies Under the Physician Fee Schedule and Other Changes to Part B Payment and Coverage Policies; Medicare Shared Savings Program Requirements; and Medicare Prescription Drug Inflation Rebate Program; Correction.
Key regulatory references include:
Course SKU
FR-26-1798-1
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