Reclassification of Hepatitis B Virus Assay Devices: Implications and Opportunities

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Reclassification of Hepatitis B Virus Assay Devices: Implications and Opportunities

Name: Reclassification of Hepatitis B Virus Assay Devices: Implications and Opportunities
SKU: FR-24-212-1
Availability: InStock

$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”.

SKU: FR-24-212-1 Categories: 2024, Federal Actions, Government and Regulatory Affairs, Healthcare and Public Health, Legal and Law Enforcement, Proposed Rule Tags: HHS-Health and Human Services Department, HHS:Food and Drug Administration Course: Reclassification of Hepatitis B Virus Assay Devices: Implications and Opportunities

Additional information

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.

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