$19.99
Stay current with the latest FDA regulatory developments for pharmacogenetic assessment systems. This course delivers clear, actionable guidance on the implications of classifying these devices as class II with special controls under 21 CFR 862.3364. Learn the specific compliance steps for manufacturers, validation and labeling requirements, reporting obligations, and the risks of non-compliance. Equip your team to confidently meet regulatory expectations and maintain market access for innovative pharmacogenetic technologies.
In this course you will learn the following:
* Understand the FDA’s rationale for classifying pharmacogenetic assessment systems as class II devices.
* Identify the special controls and general controls required for compliance.
* Implement the necessary steps to meet labeling, validation, and reporting requirements.
* 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”.
Why This Course is Important
Without this course, you risk misunderstanding or overlooking critical FDA compliance requirements, exposing your organization to enforcement actions, product recalls, or loss of market access.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Pharmacogenetic Assessment System.
Key regulatory references include:
Course SKU
FR-25-1488-1
CourseAvenue eLearning Platform has helped Federal agencies (and their suppliers) successfully address their most complex eLearning accessibility challenges.
Why This Course is Important
Without this course, you risk non-compliance with FDA regulations, potential recalls, legal penalties, and missed opportunities for streamlined product development involving beetroot red.
Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Listing of Color Additives Exempt From Certification; Beetroot Red.
Key regulatory references include:
Course SKU
FR-26-1721-1
Federal Register Title
This benchmark will help determine your readiness for: Federal Register Document titled Project-Level Predecisional Administrative Review Process. Document Number: 2026-02392
Buy this Course
FR-26-1720-1
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