Discover how the final rule from the CDC expands access to the World Trade Center (WTC) Health Program, now including Pentagon and Shanksville responders. This course unpacks the statutory changes, capped at 500 new enrollees, detailing the impact and compliance with...
Reclassification of Hepatitis B Virus Assay Devices: Implications and Opportunities
$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”.
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. |