This course provides a detailed, actionable guide to meeting FDA requirements for cancer predisposition risk assessment systems classified under 21 CFR 866.6090. Learn the full spectrum of compliance obligations—labeling, technical documentation, user comprehension study design, and website transparency—necessary for regulatory clearance and ongoing market access. Avoid costly mistakes and ensure your device meets both special and general controls, safeguarding user safety and supporting innovation in cancer genetic testing.
In this course you will learn the following:
* Understand the regulatory background and rationale for the device’s classification.
* Identify and implement the special controls and general controls required for compliance.
* Prepare and maintain required labeling, technical documentation, and user comprehension studies.
* Recognize the legal and financial consequences of failing to comply with the final rule.
