Scope
Label Review
$299/SKU
Written review for labels and claims before launch or marketplace submission.
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Transparent starting fees, with scope confirmed before work begins.
Government fees and service fees are separate. Complex matters are scoped after intake.
Scope
FDA US Agent
$499/year
US Agent designation and correspondence coordination for eligible foreign establishments.
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MoCRA Package
$899
Facility and product listing preparation support with label readiness review.
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510(k) Readiness
Custom
Classification, predicate, and readiness support scoped after device intake.
Request quoteGovernment fees are separate. FDA user fees, establishment fees, and official review fees are paid directly to FDA when applicable.