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CourseAvenue eLearning Platform has helped Federal agencies (and their suppliers) successfully address their most complex eLearning accessibility challenges.
Why This Course is Important
Participants will miss crucial insights into navigating FDA’s Class II classification, which could impact compliance and market access for microbial nucleic acid devices.
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 Microbial Nucleic Acid Storage and Stabilization Device.
Key regulatory references include:
Course SKU
FR-25-1329-1
Why This Course is Important
Failing to understand and apply the new special controls could lead to compliance issues, regulatory setbacks, and missed opportunities in device innovation.
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 Device To Detect and Measure Non-Microbial Analytes To Aid in the Detection and Identification of Localized Human Infections.
Key regulatory references include:
Course SKU
FR-25-1328-1
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