Stay up-to-date with the FDA’s latest classification for the medial knee implanted shock absorber. This course provides targeted training for orthopedic device professionals, covering the specific requirements under 21 CFR 888.3610, including special controls, clinical data, non-clinical testing, and compliance steps. Learn the actionable processes manufacturers and sponsors must follow to ensure continued market access and avoid regulatory penalties.
In this course you will learn the following:
* Understand the FDA’s rationale for classifying the medial knee implanted shock absorber as a class II device.
* Identify the special controls and general controls applicable to this device type.
* Implement the required steps to ensure compliance with the new classification and special controls.
* Recognize the legal and regulatory consequences of failing to comply with the final rule.
