Stay at the forefront of regulatory compliance with this targeted training on the FDA’s rule classifying anti-tumor necrosis factor alpha (TNF-alpha) monoclonal antibody test systems for inflammatory bowel disease as class II devices with special controls. Learn the specific compliance steps, documentation requirements, and labeling standards that manufacturers and sponsors must meet for Crohn’s disease and ulcerative colitis diagnostic products. Avoid costly missteps and ensure your team is ready for successful 510(k) submissions.
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 ensure compliance with the new classification.
* Recognize the legal and regulatory consequences of failing to comply.
