Stay ahead in the medical device industry with essential knowledge of the FDA’s classification and special controls for implanted tibial electrical urinary continence devices. This course breaks down the specific regulatory requirements, performance testing standards, and labeling mandates that manufacturers and sponsors must meet to achieve market clearance. Learn how to comply with both general and special controls, and understand the regulatory pathways that expedite innovation while ensuring patient safety.
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.
* Implement the required testing, labeling, and documentation to ensure compliance.
* Recognize the regulatory pathways for marketing these devices.
* Understand the legal and financial consequences of non-compliance.
