Stay ahead of regulatory requirements with this in-depth course on the FDA’s final rule classifying the mechanical deviation device for esophageal protection during cardiac ablation as a class II device with special controls. Learn the specific obligations for manufacturers and sponsors, including performance testing, sterility, biocompatibility, shelf life, labeling, and actionable compliance steps. Ensure your team is prepared to meet FDA standards, reduce regulatory risk, and support innovative patient care.
In this course you will learn the following:
* Understand the FDA’s rationale for classifying the device as class II with special controls.
* Identify the specific special controls and general controls applicable to this device type.
* Outline the steps required to achieve and maintain compliance with the new classification.
* Recognize the legal and regulatory consequences of failing to comply with the final rule.
