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.
