Transportation and Infrastructure

Why This Course is Important
Without this course, manufacturers and sponsors risk missing vital regulatory updates, leading to potential denial of market access, costly recalls, or enforcement actions for non-compliance with FDA requirements.

Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use.

Key regulatory references include:

• 21 CFR Part 870 – Cardiovascular Devices

Course SKU
FR-26-3260-1