Government and Regulatory Affairs

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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...

Government and Regulatory Affairs

Safety Measures for Safran Helicopter Engines: Proposed AD Overview

FAA Airworthiness Directive Compliance for Rolls-Royce Engines

FAA’s Proposed Airworthiness Rule for Pilatus PC-24

CY 2026 Medicare and Medicaid Final Rule: Compliance and Implementation

Trichloroethylene (TCE) Regulation Postponement under TSCA

Beneficial Ownership Information Compliance Course

Compliance with Updated Unaccompanied Children Program Rule

Nonprescription Drug Products: Navigating New FDA Conditions

Comprehensive Guide to Horse Protection Amendments

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LATEST Products

FDA’s Class II Classification of Microbial Nucleic Acid Devices

FDA Classification of Non-Microbial Analyte Detection Devices