FDA’s Final Rule on Radiological Device Classification

Gain comprehensive knowledge on the FDA’s final rule for the radiological acquisition and/or optimization guidance system, now classified as class II. Explore the implications of special controls on compliance, innovation, and patient safety in medical device regulation.

In this course you will learn the following:
* Understand the classification process and criteria for the radiological acquisition and/or optimization guidance system.
* Identify the special controls required for compliance with the new classification.
* Recognize the impact of this classification on regulatory burdens and patient access to innovative devices.