Stay ahead in the orthopedic device market with targeted training on the FDA’s classification of intraoperative surgical angle measurement tools. Learn about the new class II designation, special controls, and mandatory 510(k) requirements directly impacting design, testing, labeling, and documentation. This course provides practical steps for manufacturers, regulatory professionals, and sponsors to ensure product compliance, reduce regulatory burdens, and maintain access to the U.S. healthcare market.
In this course you will learn the following:
* Understand the FDA’s rationale for classifying the intraoperative surgical angle measurement tool as a class II device.
* Identify the special controls and general controls applicable to this device type.
* Implement the required testing, labeling, and documentation to ensure compliance.
* Recognize the legal and regulatory consequences of failing to comply with the final rule.
