BROKERS ASSOCIATION SEMINAR SPECIAL PRODUCT REQUIREMENTS

1. BROKERS ASSOCIATIONSEMINARSPECIAL PRODUCT REQUIREMENTS January 22, 2009 Chicago District/FDA

2. Ryan Gibson, Investigator • Human Drugs • Animal Drugs • Medical Devices • Medical Devices That Emit Radiation • Non-Medical Devices That Emit Radiation • Devices: Sunglasses/Reading Glasses • Regulations • Biological Products • Biological Numbers

3. Human Drugs • DLS – Drug Listing Number from the Foreign Manufacturer • NDA – New Drug Application from the U.S. Firm • IND –Investigation New Drug • ANDA – Abbreviated New Drug Application • http://www.fda.gov/

5. ANIMAL DRUGS • NAD – New Animal Drug Application Number – Number issued by FDA/CVM to a U.S. Firm/Sponsor • ANA – Abbreviated New Animal Drug Number – Number issued by FDA/CVM to a U.S. Firm/Sponsor • DLS – Drug Listing Number from the Foreign Manufacturer • INA – Investigational New Animal Drug • http://www.fda.gov/

6. MEDICAL DEVICES DEV – Registration number for Importer LST – Medical Device Listing Number PMN – Premarket Notification (510(k)#) PMA – Premarket Approval (“P”#) IDE - Investigational Device Exemption http://www.fda.gov/

7. Medical Devices That Emit Radiation • DEV – Registration Number For Importer • LST – Medical Device Listing Number • PMN – 510 (k) Number • ACC – Accession number • 2877 Form – 4 parts to the form A, B, C, D

9. Non-Medical Devices That Emit Radiation • ACC – Accession number from manufacturer • 2877 Form – RAA, RAB , RAC, RAD • MDL – Model Number

10. Devices Sunglasses or Reading Glasses • DEV – Registration number for Importer • LST – Medical Device Listing Number • IRC – Impact Resistance Lens Certificate

12. Regulations (CFR) • Use this code plus the qualifier to inform FDA that a product is exempted. Most of FDA’s regulations are in Title 21.

13. Biological Products • BFL – Biological Establishment License Number • BPL-Biologic Product Number Biological License Number can be provided using either AofC

14. Biologic Numbers • Biologic 510(k) BK960002 Use Device AofC PMN • Biologic PMA BP000028 Use Device AofC PMA • NDA BN 040083 Use Drug AofC NDA

15. Susan Ciani, Investigator • Cosmetics • LACF/AF: Low Acid Canned Foods and Acidified Foods • IFE: Import For Export

16. Cosmetics • If it is a drug, it requires foreign DLS. • Concerns about • Permitted colors • BSE • Microbiological content

17. LOW ACID/ACIDIFIED FOODS • FCE – Food Canning Establishment Number • Container Dimensions for jars, cans and pouches. • SID – Schedule Identifier Number

18. LOW ACID/ACIDIFIED FOODS PRODUCT CODING CONSIDERATIONS • Subclass is important to identifying products subject to LACF Regulations Products that are not hermetically sealed are exempt from LACF Regulations • Subclass E (Metal), C (Glass), V (Vacuum or Modified Atmosphere Packgaing)

19. LOW ACID/ACIDIFIED FOODS PRODUCT CODING CONSIDERATIONS • PIC is important to determining which products are subject to LACF Regulations • PIC E Commercially Sterile: Product is packed in hermetically sealed container and heat treated to achieve commercial sterility • PIC I Acidified: Low Acid Foods that are hermetically sealed to which acid is added

20. LOW ACID/ACIDIFIED FOODS PRODUCT CODING CONSIDERATIONS • Examples • Canned Tuna/Commercially Sterile 16AEE45/ Fish/ Metal / Commercially Sterile / Tuna (Albacore, Yellowfin, Bluefin, Skipjack, Etc.) • Canned Artichokes/Acidified 24TEI01 Leaf / Stem Veg/ Metal / Acidified / Artichoke (Leaf & Stem Vegetable)

21. Import for Export • Product will be imported into the U.S. but will be exported. • Does not require a qualifier. • Allows for importation of violative articles.