2025

Showing 298–306 of 629 resultsSorted by latest

FDA Classification and Special Controls for Vaginitis and Bacterial Vaginosis Diagnostic Devices
$19.99
FDA Requirements for Mutation Detection Tests in Myeloproliferative Neoplasms
$9.99
FDA Regulation: Class II Classification of Menopause Test Systems
$19.99
FDA Compliance Training: Pharmacogenetic Assessment System Device Classification (21 CFR 862.3364)
$19.99
FDA Requirements for Liver Iron Imaging Companion Diagnostics in Deferasirox Therapy
$19.99
FDA Regulation of Orthopedic Manual Surgical Instruments for Non-Fusion Spinous Process Spacer Devices
$19.99
FDA Class II Classification for Laparoscopic Gastrointestinal Sizing Tools
$19.99
FDA Rule: Anti-Phospholipase A2 Receptor Immunological Test System Classification & Compliance
$19.99
FDA Compliance for Cancer Predisposition Risk Assessment Systems (21 CFR 866.6090)
$49.99

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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

2025

FDA Classification and Special Controls for Vaginitis and Bacterial Vaginosis Diagnostic Devices

FDA Requirements for Mutation Detection Tests in Myeloproliferative Neoplasms

FDA Regulation: Class II Classification of Menopause Test Systems

FDA Compliance Training: Pharmacogenetic Assessment System Device Classification (21 CFR 862.3364)

FDA Requirements for Liver Iron Imaging Companion Diagnostics in Deferasirox Therapy

FDA Regulation of Orthopedic Manual Surgical Instruments for Non-Fusion Spinous Process Spacer Devices

FDA Class II Classification for Laparoscopic Gastrointestinal Sizing Tools

FDA Rule: Anti-Phospholipase A2 Receptor Immunological Test System Classification & Compliance

FDA Compliance for Cancer Predisposition Risk Assessment Systems (21 CFR 866.6090)

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LATEST Products

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

FDA Compliance for High Throughput DNA Sequencing Cancer Test Systems