Why This Course is Important
Missing this course could result in overlooked opportunities for regulatory streamlining, non-compliance risks, and missed chances to influence FDA policy affecting accessory classification.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Classification of Accessories Distinct From Other Devices; Proposed List of Accessories Suitable for Class I; Request for Comments.
Key regulatory references include:
- 21 CFR Part 870 – Cardiovascular Devices
- 21 CFR Part 876 – Gastroenterology-Urology Devices
- 21 CFR Part 878 – General and Plastic Surgery Devices
Course SKU
FR-26-2152-1