Why This Course is Important
A comprehensive understanding of how the FDA’s classification impacts regulatory compliance and access to innovative diagnostic tools, potentially leading to lost opportunities in leveraging these technologies effectively.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Immunology and Microbiology Devices; Classification of the Cytomegalovirus Nucleic Acid Detection Device for Congenital Cytomegalovirus Infection.
Key regulatory references include:
Course SKU
FR-25-1325-1