Stay ahead of regulatory changes with this comprehensive course focused on the FDA’s final rule for classifying flushing and storage solutions for vascular autografts at room temperature. Learn what it takes to bring your device into compliance with class II special controls, including detailed clinical and non-clinical requirements, labeling standards, and the 510(k) premarket notification process. Equip yourself to minimize business risk, ensure patient safety, and keep your products on the market.
In this course you will learn the following:
* Understand the scope and intent of the FDA’s final rule for this device type.
* Identify the key requirements and special controls now enforceable by law.
* Implement the necessary steps to achieve and maintain compliance.
* Recognize the legal and regulatory consequences of non-compliance.
