national center for toxicological research

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November 18, 2013

How Does the FDA Regulate Medical Devices?

There are many basic regulatory requirements that manufacturers and importers consider when they market medical devices. These rules are to aid foreign governments to understand the overall mission of the FDA. In addition, there are FDA regulations for marketing and exporting medical devices to and in the United States. It is very important to know the requirements and to know which ones are applicable for your product. Establishment registration, device listing, labeling requirements, classification, Pre-market notification [510(k)], medical device reporting, and good manufacturing practices are all significant to manufacturers and importers of medical devices. Here are some of the aspects of these requirements.