Post

Export Certification Process and Requirements for FDA-Regulated Products

This guidance provides a general description of FDA export certification processes for industry and foreign governments. It covers various types of export certificates issued by FDA for different product categories including biologics, drugs, medical devices, food, cosmetics, and veterinary products.

  1. Verify product and establishment eligibility for desired certificate type
  2. Ensure current registration and listing with FDA is maintained
  3. Confirm compliance with applicable CGMP regulations
  4. Submit complete certification request with required documentation
  5. Pay applicable fees for certificates under section 801(e)(4)
  6. Allow 20 government working days for processing
  7. Ensure export compliance with other U.S. regulations
  8. Maintain truthful and accurate information in certification requests
  9. Monitor establishment and product compliance status
  10. Contact appropriate FDA center for product-specific guidance

Key Considerations

Non-clinical testing

  • Non-Clinical Research Use Only Certificate available for products intended for non-clinical research use only
  • Products must be labeled according to 21 CFR 312.160 or 809.10(c)(2)

Labelling

  • Products must be properly labeled as authorized in the United States
  • For unapproved products, specific labeling requirements apply under sections 801(e) and 802 of the FD&C Act

Safety

  • Manufacturing establishments must be in compliance with applicable CGMP regulations
  • FDA bases compliance certification on most recent inspection and available information
  • FDA will not issue certificates if enforcement actions are ongoing

Other considerations

  • 21 CFR 312.160: Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
  • 21 CFR 809.10(c)(2): Labeling Requirements for In Vitro Diagnostic Products

Original guidance

  • Export Certification Process and Requirements for FDA-Regulated Products
  • HTML / PDF
  • Issue date: 2021-08-20
  • Last changed date: 2024-10-01
  • Status: FINAL
  • Official FDA topics: Export, Medical Devices, Food & Beverages, Drugs, Animal & Veterinary, Biologics, Import
  • ReguVirta summary file ID: bc0355e1558c9d81d41a013ebcd1903d
This post is licensed under CC BY 4.0 by the author.