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FDA regulates the sale of medical device products in the U.S. and monitors the safety of all regulated medical products. Information for consumers and health care providers, letters to industry.

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The CDRH Standards ProgramCreated as a result of the Food and Drug Administration Modernization Act (FDAMA) of 1997. The Standards Management Staff (SMS) is responsible for facilitating the recognition of national and international medical device consensus standards.

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The .gov means its official. Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

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