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...
FDA’s Reclassification of CMV DNA Assay Devices
Discover the significant changes brought by the FDA’s final order on cytomegalovirus (CMV) DNA quantitative assay devices for transplant patient management. Learn about the implications of reclassification from class III to class II, including special controls and the premarket notification requirement, and how these changes impact compliance, safety, and effectiveness.
In this course you will learn the following:
* Understand the regulatory background and rationale for the reclassification of CMV transplant assays.
* Identify the key requirements and special controls associated with class II devices.
* Recognize the steps necessary for compliance with the new classification.
* Comprehend the consequences of non-compliance with the reclassification order.
Additional information
| Federal Register Title | Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management. Document Number: 2024-21616 |
|---|---|
| Course SKU | FR-24-214-1 |
| Why This Course Is Important | Failing to stay updated on the FDA's reclassification could lead to non-compliance and jeopardize the safety and effectiveness of CMV DNA quantitative assay devices in transplant patient management. |