Why This Course is Important
Without this course, you risk citing outdated regulations, creating compliance gaps, and facing potential delays or scrutiny during FDA reviews or inspections.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Quality Management System Regulation Technical Amendments.
Key regulatory references include:
- 21 CFR Part 801 – Labeling
- 21 CFR Part 803 – Medical Device Reporting
- 21 CFR Part 812 – Investigational Device Exemptions
- 21 CFR Part 860 – Medical Device Classification Procedures
- 21 CFR Part 862 – Clinical Chemistry and Clinical Toxicology Devices
Course SKU
FR-25-1622-1