HHS:Food and Drug Administration Archives - Page 16 of 21

FDA 510(k) Exemption for Class II Clinical Toxicology Test Systems: Compliance and Implementation

Oct 7, 2026

Why This Course is Important
Without this training, manufacturers and stakeholders risk failing to comply with the new exemption requirements, exposing their companies to enforcement actions, unnecessary 510(k) submissions, or loss of market access for clinical toxicology test systems.

Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Medical Devices; Exemptions From Premarket Notification: Class II Devices; Certain Clinical Toxicology Test Systems.

Key regulatory references include:

21 CFR Part 862 – Clinical Chemistry and Clinical Toxicology Devices

Course SKU
FR-26-2249-1

FinCEN Withdrawal: Proposed Special Measure on Convertible Virtual Currency Mixing

Oct 7, 2026

Why This Course is Important
Without this course, you risk missing critical insight into regulatory shifts affecting virtual currency transactions and may be unprepared for future compliance obligations impacting your organization or clients.

Course Details
This is a self-paced eLearning course based on the Federal Register Document titled Proposal of Special Measure Regarding Convertible Virtual Currency Mixing, as a Class of Transactions of Primary Money Laundering Concern; Withdrawal.

Key regulatory references include:

31 CFR Part 1010 – General Provisions

Course SKU
FR-26-2248-1

HHS:Food and Drug Administration

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FDA’s Rule on Calcium Phosphate in Food Products

FDA Approves Expanded Use of Butterfly Pea Flower Extract

FDA’s Class II Classification of Microbial Nucleic Acid Devices

FDA Classification of Non-Microbial Analyte Detection Devices

FDA’s Classification of DNA-Based Tests in Hematological Malignancies

FDA’s Class II Classification of FISH Devices

FDA’s Classification of Cytomegalovirus Nucleic Acid Detection Device

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FDA 510(k) Exemption for Class II Clinical Toxicology Test Systems: Compliance and Implementation

FinCEN Withdrawal: Proposed Special Measure on Convertible Virtual Currency Mixing