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All device establishments must complete their annual registration for each Fiscal Year between October 1 and December 31.
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All establishments required to register must pay the user fee before registration.
$279
Medical Device Establishment Registration and US Agent Service
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Medical device establishment registration or modification.
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US agent or Correspondent communication service (During same FDA Fiscal Year).
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Include free electronic certificate.
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Free modification or renewal during service period.
We encourage you to schedule consultation for better understanding of FDA compliance.