Risk management strategies for combination products that merge drugs, devices, and/or biological products under 21 CFR Parts 211, 820, and 1271.
Risk Management Strategies for Combination Products
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Description
Risk management strategies crucial for ensuring the safety, efficacy, and quality of combination products that merge elements of drugs, devices, and/or biological products. This comprehensive guide addresses every phase of the product lifecycle, from initial design to post-market surveillance, navigating complex regulations across 21 CFR Parts 211 (pharmaceuticals), 820 (medical devices), and 1271 (biologics). Discover 14 high-priority risk management strategies including risk-based quality systems, design controls with human factors integration, validated processes, comprehensive master files, and post-market surveillance. Covers emerging 2025 requirements: cybersecurity risk management per Section 524B, AI/ML validation frameworks, Digital Supplier Verification Programs, UDI/DSCSA serialization requirements, and alignment with FDA’s Quality Management System Regulation (QMSR) effective February 2026.
