HHS-Health and Human Services Department

Why This Course is Important
Without this course, you risk overlooking essential FDA requirements, facing regulatory penalties, and losing market access for anti-TNF-alpha monoclonal antibody test systems for IBD.

Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Anti-Tumor Necrosis Factor Alpha Monoclonal Antibody Test System for Inflammatory Bowel Disease.

Key regulatory references include:

• 21 CFR Part 862 – Clinical Chemistry and Clinical Toxicology Devices

Course SKU
FR-26-2200-1