Course: Proposed Rule on Profits and Related Basis Adjustments based on this document from the Federal Register: https://www.govinfo.gov/content/pkg/FR-2024-12-02/pdf/2024-27227.pdf This document contains proposed regulations regarding previously taxed earnings and...
Reclassification of Hepatitis B Virus Assay Devices: Implications and Opportunities
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.
Additional information
| Federal Register Title | Microbiology Devices; Reclassification of Antigen, Antibody, and Nucleic Acid-Based Hepatitis B Virus Assay Devices. Document Number: 2024-21932 |
|---|---|
| Course SKU | FR-24-212-1 |
| 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. |