1. 1 Importation of Medical Devices FDA Chicago District O’Hare Import Resident Post August 26, 2010 Import Entry Review Team Tamara M. Qtami, CSO

2. 2 Medical Device Definition According to section 201(h) of the Food Drug and Cosmetic Act, a medical device is defined as: “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

3. 3 Medical Device Definition recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

4. 4 Background Information The Medical Device Amendments of 1976 followed a U.S. Senate finding that faulty medical devices had caused 10,000 injuries, including 731 deaths. The law applied SAFETY and EFFECTIVENESS safeguards to new devices.

5. 5 Before an Entry is Submitted You should have answers to the following: Is this product a medical device? If so, what is the device Classification? What is required for a device under this classification? Is the Foreign Manufacturer registered? Is the Importer of Record registered? Is the LST/510(k)/PMA in the Affirmation of Compliance valid? Is the product or manufacturer on Import Alert?

6. 6 Where to Find the Answers The FDA website is designed to be a helpful resource tool to determine: Product code and device classification Listing information and 510(k) or PMA exemption Registration information for foreign manufacturers, importers and contractors Import Alert status if it is relevant to entry

7. 7 Device Classification

8. 8 Click on Medical Devices, scroll to middle of page to Industry Assistance

9. 9 Device Classification

10. 10 Device Classification

11. 11 Device Classification

12. 12 Establishment Registration Click on Registration and Listing

13. 13 Establishment Registration INVESTIGATIONS OPERATIONS MANUAL, EXHIBIT 5-13 http://www.fda.gov/ICECI/Inspections/IOM/default.htm

14. 14 IOM Exhibit 5-13

15. 15 IOM Exhibit 5-13 Print and use as a reference:

16. 16 Documents Required?! We understand that you may be under time constraints, but if we do not have the information that we need, your entry will be on hold and require further review.

17. 17 Documents Required?! Documents are required when there are discrepancies in an entry. Each entry should be submitted with complete and accurate information upon a thorough review of the documents provided from the Importer.

18. 18 When Sending Documents Review the entry submitted and determine what the reason for request could be. If Affirmation of Compliance is incomplete or information is invalid, please ensure that documents you are sending include the correct information. Much time has been spent reviewing documents that are insufficient.

19. 19 When Sending Documents Important Note: Are the products United States Goods Returned? If so, WE NEED TO KNOW THE REASON WHY THE GOODS ARE BEING RETURNED. When sending documents, please be sure to include this information in the packet, or include in the “corrected description” portion for that line in the entry.

20. 20 When the “Ducks are in a Row”

21. 21 We should hope to be smooth sailing from there! Thank you for your attention!