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With 35 years of medical device industry experience we provide cost effective pathways to compliance by:
The FDA regulates over 1 trillion dollars' worth of products, which accounts for 22 cents of every dollar spent annually by American consumers.
The failure to comply with any applicable provision in this part renders a device adulterated under section 501(h) of the act. Such a device, as well as any person responsible for the failure to comply, is subject to regulatory action.