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FDA Affirmations of Compliance

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Affirmations of compliance are additional pieces of information such as medical device listing, drug listing, Radiation Declaration, FCE/SIDS (canning establishment). In all, there are more than 200 different types of Affirmations of Compliance in the differing industries within FDA jurisdiction.

Requirements vary by commodity; check with your customs provider to see what applies to your product database. To help you identify what some of these codes might be, we have highlighted the most common ones, per FDA category.

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