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Navigating UDI Regulations: Key Considerations for Device Manufacturers

In the ever-evolving landscape of medical device regulations, compliance with the Food and Drug Administration’s (FDA) unique device identifier (UDI) system is crucial for device manufacturers. The FDA’s Global Unique Device Identification Database (GUDID) was established to enhance traceability, improve post-market surveillance, and ultimately ensure patient safety. Understanding FDA GUDID and UDI Requirements The FDA’s […]