HHS:Food and Drug Administration

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FDA’s Class II Classification of Microbial Nucleic Acid Devices

May 28, 2025

Gain a comprehensive understanding of the FDA's recent classification of microbial nucleic acid storage and stabilization devices into Class II with special controls. This course highlights the significance of these controls in ensuring device safety and...

FDA Classification of Non-Microbial Analyte Detection Devices

May 28, 2025

Dive into the intricacies of the FDA's new rule classifying devices designed to detect and measure non-microbial analytes. Learn about the special controls required for class II classification and how these changes can affect device manufacturers and healthcare...

HHS:Food and Drug Administration

FDA’s New Fee Structure for Color Additive Certification

FDA Proposed Rule on Ortho-Phthalates in Food Contact Applications

Reclassification of Hepatitis B Virus Assay Devices: Implications and Opportunities

FDA Produce Safety Rule: Compliance for Small Entities

FDA’s Reclassification of CMV DNA Assay Devices

FDA’s Revocation of Mutual Recognition Regulations

FDA’s New Classification of Viral Nucleic Acid Tests for Transplants

FDA Classification of Pediatric Renal Therapy Systems

FDA’s Class II Device Classification for Head and Neck Cancer Detection

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FDA’s Class II Classification of Microbial Nucleic Acid Devices

FDA Classification of Non-Microbial Analyte Detection Devices