1. BROKERS ASSOCIATION SEMINAR SPECIAL 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

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
DLS – Drug Listing Number from the Foreign Manufacturer
INA – Investigational New Animal Drug

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

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 Biologic PMA BP000028
Use Device AofC PMN
Biologic PMA BP000028
Use Device AofC PMA
NDA BN
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.