What are the FDA Regulatory Requirements for Importing Medical Devices into the U.S.?

1. What are the FDA Regulatory Requirements for Importing Medical Devices into the U.S.? Carole C. Carey carole.carey@fda.hhs.gov Director, CDRH International Staff U.S. FDA Center for Devices and Radiological Health

2. Learning Objective • Have a basic knowledge and understanding of importation process and the regulatory requirements for medical devices before they may be imported into the U.S.

3. Outline • Import Program Mission & FDA Authority • Role of FDA ORA and relationship with Customs Border Protection • Importer requirements /Import procedures • Import for Export • Sampling decisions & Automated Systems

4. To successfully assess, manage, mitigate, and to the extent possible, eliminate public health risks that FDA-regulated imported products may pose to U.S. consumers. Medical devices, and electronic products that emit radiation are FDA-regulated products and are subject to examination by FDA when they are being imported or offered for import into the United States. Mission of theImport Program

5. 801(a) U.S. Customs will notify U.S. FDA regarding the entry of regulated products, which includes medical devices. 801(b) U.S. FDA will authorize U.S. Customs to permit delivery of the regulated products or to refuse entry to the U.S. FDA Import AuthoritySection 801(a) - (d) FD&C Act

6. 801(c) Owner or consignee pays the expense incurred by FDA in connection with destruction or reconditioning of refused products 801(d)(3) discusses the conditions for importing devices which are not approved for marketing in the U.S. for subsequent export use. Import for Export FDA Import AuthoritySection 801(a) - (d) FD&C Act

7. Import for Export • The law permits U.S. firms to import components, subassemblies, unfinished devices to the U.S. for the purpose of “further processing” or “incorporation” (to include packaging labeling or sterilization) into medical devices • Requires registration, and listing, and subject to FDA audits • Statement for intent to export

8. Office of Regulatory Affairs (ORA) • ORA is the lead office for all FDA field activities as well as providing FDA leadership on imports, inspections, and enforcement policy.  

9. Office of Regulatory Affairs (ORA) • ORA supports the five FDA product centers by • inspecting regulated products and manufacturers, • conducting sample analysis on regulated products, • reviewing imported products offered for entry into the United States.  • ORA also develops FDA-wide policy on compliance and enforcement and executes FDA’s Import Strategy and Food Protection Plans. 

10. Same Standards forDomestic & Imported Devices • All imported products are required to meet the same standards and regulations as domestic goods. • devices must be safe and effective • radiation-emitting devices must meet established standards • products must contain informative and truthful labeling in English.

11. Basic authorities that provide FDA with the means to regulate medical devices. Applies to all medical devices regardless of classification, are subject to premarket and postmarket regulatory controls. Premarket notification or 510(k), if not exempt Register and List Compliant Labeling Misbranding Adulteration Quality Systems /GMP Records and Reports / (MDR) Report device failures Corrective action plans Postmarket studies, if required. General Controls(Class I, II, III Devices)

12. What is Adulteration? What is Misbranding? • Adulteration has to do with the content of a product (such as the addition of a substance which makes a product inferior, impure, not genuine, etc.) • Misbranding has to do with statements on labels or labeling that are false or misleading.

13. Foreign Manufacturers • Register Establishment and List Device (s). • In addition, must designate a United States agent. • As with domestic manufacturers, foreign manufacturing sites are subject to FDA inspection. • Evidence they were produced in a facility which has registered, licensed and/or listed its products with FDA is required. For these products, the site-specific location must be submitted as the FDA Manufacturer. • The name and address of a corporate headquarters, "trading company", or other intermediate supplier is not acceptable.

14. Initial Importer • any importer who furthers the marketing of a device from a foreign manufacturer to the person who makes the final delivery or sale of the device to the ultimate consumer or user • does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package.

15. Initial Importer • Must register establishment • Subject to • Medical Device Reporting (21 CFR 803) • (maintain an MDR event file for each adverse event) • Reports of Corrections and Removals (21 CFR 806) • All product complaints (MDR and nonMDR event must be forwarded to the manufacturer) • Medical Device Tracking 21 CFR 821, if applicable • (tracked through the distribution chain)

16. Import Procedures • U.S. Importer posts bond, pays duty, and obtains permit from U.S. CBP • U.S. CBP submits invoices of regulated products to FDA When an entry is filed with CBP, a copy of the entry is also provided to the local FDA district office. The FDA district office then determines if the product complies with FDA requirements.

17. Import Procedures (cont’d) • FDA decides whether to examine and/or sample shipment , or to release shipment without examination. • In-compliance shipments - Released • Violative samples - Detained • Auto detention - All products from listed Exporters or Exporting Countries are Automatically Detained without sampling Form FDA 2877 (Declaration for Radiation Standard) is required for radiation-emitting electronic products entering the United States. “Notice of FDA Action”

18. Sampling Decisions • FDA sets sampling priorities • Risk analysis decision on product sampling • Majority released without examination • Examination may be visual (labeling) or laboratory analysis • Some products are 100% sampled, e.g., condoms

19. Product Examined or Sampled • If shipment passes examination – Admitted • If shipment fails – Entry denied and detained • Detained shipment: - May be moved to nearby warehouse - Requires FDA (not CBP) Release for destruction, re-export, or reconditioning. • If reconditioning passes – Entry allowed - Reconditioning fails – Destroy or Re-export

20. FDA Automated System OASIS System (Operational and Administrative System for Import Support) • OASIS is an automated FDA system for processing and making admissibility determinations for shipments of foreign-origin, FDA-regulated products seeking to enter U.S. commerce.

21. Using OASIS System • Broker enters data into the CBP System • If it is a device, CBP prompts Broker • Broker enters OASIS system, and enters data • OASIS System makes a risk assessment based on Broker’s data – shipment released, or, shipment detained for examination. Import Refusals involving FDA-regulated products are listed in Import Refusal Reports for OASIS, updated monthly.

23. PREDICT System • FDA's new PREDICT risk-based screening system for imports is coming soon. • It will replace the admissibility screening function of OASIS, FDA's legacy system. • PREDICT will assist entry reviewers in targeting higher-risk shipments for examination. • It will also expedite the clearance of lower-risk cargo, but only if accurate and complete data are provided by importers and entry filers.

24. Summary • Federal Food, Drug, and Cosmetic (FD&C) Act and other laws apply equally to domestic and imported products. • FDA does not recognize regulatory approvals from foreign countries. • Medical devices and radiation-emitting products must meet FDA regulations prior to the importation into the United States. • All foreign firms are required to both register their establishments, identify a U.S. Agent, and individually list their devices before they may import them into the United States.

25. Referenceshttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ImportingandExportingDevices/ucm050126.htmReferenceshttp://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ImportingandExportingDevices/ucm050126.htm • Regulatory Procedures Manual, Chapter 9, Import Procedures • FDA Investigations Operations Manual, Chapter 6, Imports • Import Alerts • Import Program System Information • Regulatory Procedures Manual. • Food Drug & Cosmetic Act

26. Compliance Policy Guides • Export of FDA Regulated Products from U. S. Foreign Trade Zones, Compliance Policy Guide, Section 110.200 (CPG 7150.11) • Food and Drug Guaranty - Imports, Compliance Policy Guide, Section 110.500 (CPG 7153.10) • FDA Authority Over Products of Foreign Origin Located in Foreign Trade Zones, Bonded Warehouses or on Bonded Carriers, Compliance Policy Guide, Section 110.600 (CPG 7150.14) • Seizures by the U. S. Customs Service of Prohibited Articles of Foreign Origin Not Intended for Entry into the United States, Compliance Policy Guide, Section 110.700 (CPG 7153.08) • Imports, Post Detention Sampling, Compliance Policy Guide, Section 110.800 (CPG 7150.04) • Imported Products - Lack of English Labeling, Compliance Policy Guide, Section 110.900 (CPG 7150.15)

27. FDA Office of Regulatory AffairsDiv. of Import Operation & Policy, HFC-1705600 Fishers Lane, Rockville, MD 20850 (301) 443-6553 FAX (301) 594-0413 FDA Center for Devices and Radiological HealthDivision of Small Manufacturers, International and Consumer Assistance 10903 New Hampshire Ave, Silver Spring, MD 20993-0002 (800) 638-2041 FAX (301) 847-8149. Manufacturers outside the U.S. should call (301) 796-7100 Email dsmica@fda.hhs.gov For more information…

28. Thank you!