FDA Classification and Compliance for Hematopoietic Cell Enrichment Kits
Stay ahead of regulatory changes with our focused training on the FDA’s new classification of hematopoietic cell enrichment kits as class II medical devices. This course delivers targeted guidance for manufacturers, sponsors, and laboratories on meeting special controls, fulfilling 510(k) submission requirements, and implementing robust design, labeling, and validation protocols under 21 CFR 866.6120. Ensure uninterrupted market access by understanding actionable compliance steps and avoiding costly enforcement actions.
In this course you will learn the following:
* Understand the FDA’s rationale for classifying hematopoietic cell enrichment kits as class II devices.
* Identify the special controls and general controls applicable to these devices.
* Implement the required design, labeling, and validation measures to ensure compliance.
* Recognize the legal and regulatory consequences of failing to comply with the final rule.
NOTE: Unless otherwise indicated, all course purchases are for access to the course for a period of 1-year. At the end of the one year term, the course will be set to “inactive”.
