HHS:Food and Drug Administration Archives - Page 15 of 21

FDA Rule: Class II Classification for Hyperoxia Monitoring Device Adjunct to Pulse Oximetry

Oct 7, 2026

Why This Course is Important
Without this course, you risk missing critical compliance deadlines, misunderstanding special control requirements, and facing potential enforcement actions that could delay or block your product’s entry to market.

Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Cardiovascular Devices; Classification of the Hyperoxia Monitoring Device Adjunct to Pulse Oximetry.

Key regulatory references include:

21 CFR Part 870 – Cardiovascular Devices

Course SKU
FR-26-2251-1

FDA Compliance for High Throughput DNA Sequencing Cancer Test Systems

Oct 7, 2026

Why This Course is Important
Without this course, you risk overlooking critical FDA special controls, which can lead to device reclassification, legal penalties, and loss of market access for your hereditary cancer DNA sequencing products.

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 High Throughput DNA Sequencing for Hereditary Cancer Predisposition Assessment Test System.

Key regulatory references include:

21 CFR Part 866 – Immunology and Microbiology Devices

Course SKU
FR-26-2250-1

HHS:Food and Drug Administration

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FDA Rule: Class II Classification for Hyperoxia Monitoring Device Adjunct to Pulse Oximetry

FDA Compliance for High Throughput DNA Sequencing Cancer Test Systems