Why This Course is Important
Without this course, manufacturers and stakeholders risk missing critical updates on compliance deadlines, special controls, and documentation requirements—jeopardizing market access, exposing the business to enforcement actions, and potentially causing operational disruptions.
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 SARS-CoV-2 Serology Test.
Key regulatory references include:
Course SKU
FR-26-2036-1