1. Medical Device Quality Systems Workshop
April 11-12, 2000
What are the FDA Regulatory Requirements for Importing Medical Devices into the U.S.?
Carole C. Carey
Director, CDRH International Staff
U.S. FDA Center for Devices and Radiological Health
US Food & Drug Administration, Division of Small Manufacturers Assistance

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.
U.S. Food & Drug Administration

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
U.S. Food & Drug Administration

4. Mission of the Import Program
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.
U.S. Food & Drug Administration

5. FDA Import Authority Section 801(a) - (d) FD&C Act
Medical Device Quality Systems Workshop
April 11-12, 2000
FDA Import Authority Section 801(a) - (d) FD&C Act
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.
Under certain conditions violative products may be reconditioned in lieu of re-export or destruction
Firm’s must submit reconditioning proposals to FDA District office
FDA may, or may not, grant permission to recondition,at its discretion
U.S. Food & Drug Administration
US Food & Drug Administration, Division of Small Manufacturers Assistance

6. FDA Import Authority Section 801(a) - (d) FD&C Act
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
U.S. Food & Drug Administration

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
U.S. Food & Drug Administration

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.  
U.S. Food & Drug Administration

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. 
U.S. Food & Drug Administration

10. Same Standards for Domestic & 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.
U.S. Food & Drug Administration

11. General Controls (Class I, II, III Devices)
Medical Device Quality Systems Workshop
April 11-12, 2000
General Controls (Class I, II, III Devices)
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.
If your device is a type that requires a premarket notification (or 510(k)) submission, you are required to submit a 510(k) when the following occurs: (a) a foreign manufacturer intends to export a medical device to the U.S. that the firm has never before shipped to the U.S.;
(b) either the foreign manufacturer or initial distributor changes the intended uses of devices that are legally being marketed in the U.S.; or
(c) changes or modifications to a legally marketed device that could significantly affect its safety or effectiveness.
Establishment Registration (use FDA Form 2891) of companies which are required to register under 21 CFR Part , such as manufacturers, distributors, repackages and relabelers. Foreign establishments, however, are not required to register their establishments with FDA.
Medical Device Listing with FDA of devices to be marketed.
Manufacturing devices in accordance with Good Manufacturing Practices (GMP) in 21 CFR Part 820.
Labeling devices in accordance with labeling regulations in 21 CFR Part 801 or 809.
Submission of a premarket notification [510(k)] before marketing a device.
Misbranding is False or Misleading labeling
Manufacturers. Importers and distributors must maintain records of reports to assure that devices are not adulterated and misbranded
U.S. Food & Drug Administration
US Food & Drug Administration, Division of Small Manufacturers Assistance

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.
U.S. Food & Drug Administration

13. Foreign Manufacturers
Medical Device Quality Systems Workshop
April 11-12, 2000
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.
FDA Manufacturer: The FDA Manufacturer is the site-specific location where the product is manufactured, produced, or grown.
FDA Shipper: The FDA Shipper is the actual shipper of the product identified on freight bills or bills of lading and is often the same as the USCS invoicing party.
U.S. Food & Drug Administration
US Food & Drug Administration, Division of Small Manufacturers Assistance

14. Medical Device Quality Systems Workshop
April 11-12, 2000
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.
Initial Importers
The initial importer of the device must register its establishment with FDA. An initial importer is 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, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. Registration information can be found under Establishment Registration.
Initial importers are also subject to Medical Device Reporting (MDR) under 21 CFR 803, Reports of Corrections and Removals under 21 CFR 806, and Medical Device Tracking under 21 CFR 821, if applicable. Under the MDR regulations importers are required to report incidents in which a device may have caused or contributed to a death or serious injury as well as report certain malfunctions. The importers must maintain an MDR event file for each adverse event. All product complaints (MDR and nonMDR events) must be forwarded to the manufacturer. Under Medical Device Tracking requirements, certain devices must be tracked through the distribution chain.
U.S. Food & Drug Administration
US Food & Drug Administration, Division of Small Manufacturers Assistance

15. Medical Device Quality Systems Workshop
April 11-12, 2000
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)
Initial Importers
The initial importer of the device must register its establishment with FDA. An initial importer is 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, but does not repackage, or otherwise change the container, wrapper, or labeling of the device or device package. Registration information can be found under Establishment Registration.
Initial importers are also subject to Medical Device Reporting (MDR) under 21 CFR 803, Reports of Corrections and Removals under 21 CFR 806, and Medical Device Tracking under 21 CFR 821, if applicable. Under the MDR regulations importers are required to report incidents in which a device may have caused or contributed to a death or serious injury as well as report certain malfunctions. The importers must maintain an MDR event file for each adverse event. All product complaints (MDR and nonMDR events) must be forwarded to the manufacturer. Under Medical Device Tracking requirements, certain devices must be tracked through the distribution chain.
U.S. Food & Drug Administration
US Food & Drug Administration, Division of Small Manufacturers Assistance

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.
U.S. Food & Drug Administration

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”
U.S. Food & Drug Administration

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
U.S. Food & Drug Administration

19. Product Examined or Sampled
Medical Device Quality Systems Workshop
April 11-12, 2000
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
Under certain conditions violative products may be reconditioned in lieu of re-export or destruction
Firm’s must submit reconditioning proposals to FDA District office
FDA may, or may not, grant permission to recondition,at its discretion
Importer can petition to recondition the goods to bring them into compliance.
Relabeling a misbranded product
Cleansing an adulterated product
Making a product not FDA-regulated
U.S. Food & Drug Administration
US Food & Drug Administration, Division of Small Manufacturers Assistance

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.
U.S. Food & Drug Administration

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.
U.S. Food & Drug Administration

22. U.S. Food & Drug Administration

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.
U.S. Food & Drug Administration

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.
U.S. Food & Drug Administration

25. References http://www. fda
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
U.S. Food & Drug Administration

26. Compliance Policy Guides
Export of FDA Regulated Products from U. S. Foreign Trade Zones, Compliance Policy Guide, Section (CPG )
Food and Drug Guaranty - Imports, Compliance Policy Guide, Section (CPG )
FDA Authority Over Products of Foreign Origin Located in Foreign Trade Zones, Bonded Warehouses or on Bonded Carriers, Compliance Policy Guide, Section (CPG )
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 (CPG )
Imports, Post Detention Sampling, Compliance Policy Guide, Section (CPG )
Imported Products - Lack of English Labeling, Compliance Policy Guide, Section (CPG )
U.S. Food & Drug Administration

27. Medical Device Quality Systems Workshop
April 11-12, 2000
For more information…
FDA Office of Regulatory Affairs Div. of Import Operation & Policy, HFC Fishers Lane, Rockville, MD (301) FAX (301)
FDA Center for Devices and Radiological Health Division of Small Manufacturers, International and Consumer Assistance New Hampshire Ave, Silver Spring, MD
(800) FAX (301) Manufacturers outside the U.S. should call (301)
Information concerning premarket notification, radiation control standards, or device listing and establishment registration, is available at Device Advice: Device Regulation and Guidance.  You may also contact the
U.S. Food & Drug Administration
US Food & Drug Administration, Division of Small Manufacturers Assistance

28. Thank you!