How To Determine FDA Medical Device Classification

Medical devices are any type of device used for diagnosis, treatment, or prevention of disease or other medical conditions. The U.S. Food and Drug Administration (FDA) regulates all medical devices sold in the United States, from contact lenses and hearing aids to stents and defibrillators. To ensure devices are safe and effective, the FDA has developed a medical device classification system based on their risk profile. Before starting your regulatory pathway, you must determine your product’s correct classification.


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