Assurentry Team · February 2026
What Is FDA Import Certification?
FDA import certification is the process by which FDA confirms that certain imported products comply with US requirements. For some product types, a certificate or other documentation is needed before release.
When Certification Is Required
Certification may be required for milk and dairy, shell eggs, catfish, drugs, biologics, and devices under specific programs. The importer submits documentation through CBP and FDA systems. See FDA detention guidance if goods are held.
Certification Process and Documents
Requirements vary by product. Common documents include foreign government or third-party certificates, manufacturing attestations, and test results. Data must be submitted via ACE and associated with the entry.
Import certification support
Assurentry helps importers navigate FDA certification and documentation requirements.
Get Import HelpPrior Notice and Entry Coordination
Prior notice for food imports must be filed regardless of certification. Ensure prior notice, entry filing, and any certification data are consistent. See prior notice filing for food-specific steps.
Avoiding Delays and Refusals
Submit complete, accurate documentation before arrival. Missing or incorrect certificates cause holds and potential refusal. Plan ahead and verify requirements for your product category.
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Assurentry acts as a technical translation layer. You provide basic business info, and we automatically generate and file the exact electronic submissions required by the FDA.
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