HHS-Health and Human Services Department

Why This Course is Important
Without this course, you risk costly delays, failed 510(k) submissions, and potential enforcement actions resulting from incomplete compliance with FDA special controls for ENT surgical assist devices.

Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Ear, Nose, and Throat Devices; Classification of the Cooperative Powered Surgical Assist Device for ENT Surgery.

Key regulatory references include:

• 21 CFR Part 874 – Ear, Nose, and Throat Devices

Course SKU
FR-26-2201-1