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LATEST Products

FDA Classification and Compliance for Hematopoietic Cell Enrichment Kits

Oct 10, 2026

Why This Course is Important
Without this course, you risk costly compliance missteps, delayed product launches, and potential enforcement actions that could jeopardize your ability to market hematopoietic cell enrichment kits in the U.S.

Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Immunology and Microbiology Devices; Classification of the Hematopoietic Cell Enrichment Kit.

Key regulatory references include:

Course SKU
FR-26-3261-1

FDA Compliance for Infant Pulse Rate and Oxygen Saturation Monitors (OTC)

Oct 10, 2026

Why This Course is Important
Without this course, manufacturers and sponsors risk missing vital regulatory updates, leading to potential denial of market access, costly recalls, or enforcement actions for non-compliance with FDA requirements.

Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Cardiovascular Devices; Classification of the Infant Pulse Rate and Oxygen Saturation Monitor for Over-the-Counter Use.

Key regulatory references include:

Course SKU
FR-26-3260-1

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