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For a list of traditionally-recognized product categories that fall under FDAs regulatory jurisdiction, please visit the What Does FDA Regulate

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The methodologies for determining both of these outlier fixed-loss amounts include calculating and applying a charge inflation factor to increase charges from the claim year to the rulemaking year, as well as calculating and applying cost-to-charge ratio (CCR) adjustment factors to adjust CCRs used to make payments in the current year to the rulemaking year