Content By Jennifer Patterson Lorenzetti

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By: Jennifer Patterson Lorenzetti

Where does the U.S. Food and Drug Administration (FDA) stand on good manufacturing practices (GMP), the set of regulations that govern manufacture and testing of medical devices and other medical products like pharmaceuticals, diagnostics, and food? And what of the universal device identification?

FDA regulations

Good manufacturing practices are, in general, a quality system that follows certain basic principles. These principles govern the manufacturing process, including the control and evaluation of process changes; the drafting of documentation, including instructions and procedures; the training of operators; the records of manufacture and distribution; and the handling of recall and complaint.

According to information from the FDA, “The current good manufacturing practices requirements set forth in the quality system (QS) regulation… require that domestic or foreign manufacturers have a quality system for the design and production of medical devices intended for commercial distribution in the United States.”