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BROKERS ASSOCIATIONSEMINARSPECIAL PRODUCT REQUIREMENTS January 22, 2009 Chicago District/FDA 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 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 / 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 / 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 / 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 Non-Medical Devices That Emit Radiation ACC – Accession number from manufacturer 2877 Form – RAA, RAB , RAC, RAD MDL – Model Number Devices Sunglasses or Reading Glasses DEV – Registration number for Importer LST – Medical Device Listing Number IRC – Impact Resistance Lens Certificate 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. Biological Products BFL – Biological Establishment License Number BPL-Biologic Product Number Biological License Number can be provided using either AofC Biologic Numbers Biologic 510(k) BK960002 Use Device AofC PMN Biologic PMA BP000028 Use Device AofC PMA NDA BN