Stay current with the latest FDA requirements for temperature regulation devices used in esophageal protection during cardiac ablation procedures. This course guides medical device professionals through the new class II classification, special controls, performance testing, labeling, and 510(k) premarket notification steps. Learn what’s required for regulatory compliance, market access, and patient safety, and avoid the legal and financial risks associated with non-compliance under the FDA’s final rule.
In this course you will learn the following:
* Understand the FDA’s rationale for classifying these devices as class II.
* Identify the special controls and general controls applicable to these devices.
* Recognize the steps required for compliance, including performance testing, labeling, and premarket notification.
* Appreciate the legal and regulatory consequences of failing to comply with the new classification and controls.
