Why This Course is Important
Without this course, you risk missing vital compliance requirements, potentially resulting in regulatory penalties, loss of market access, or costly recalls due to non-compliance with FDA’s special controls.
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 Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens.
Key regulatory references include:
Course SKU
FR-26-2106-1