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FDA Requirements for Prognostic Tests Assessing Chronic Kidney Disease Progression

Jul 25, 2026

Why This Course is Important
Without this training, you may miss critical FDA requirements, risk costly delays, or face legal penalties that could prevent your CKD prognostic tests from entering the market.

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 Prognostic Test for Assessment of Chronic Kidney Disease Progression.

Key regulatory references include:

Course SKU
FR-26-2107-1

FDA Medical Device Rule: OTC SARS-CoV-2 Test Classification & Special Controls

Jul 25, 2026

Why This Course is Important
Without this course, you risk missing vital compliance requirements, potentially resulting in regulatory penalties, loss of market access, or costly recalls due to non-compliance with FDA’s special controls.

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 Over-the-Counter Test To Detect SARS-CoV-2 From Clinical Specimens.

Key regulatory references include:

Course SKU
FR-26-2106-1

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