FOR MEDICAL DEVICES医疗器械.ppt

BROKERS ASSOCIATION SEMINAR SPECIAL 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 FDAs 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 040083 Use Drug AofC NDA,Susan Ciani, Investigator,Cosmetics LACF/AF: Low Acid Canned Foods and Acidified Foods IFE: Import For Export,Cosmetics,If it is a drug, it requires foreign DLS. Concerns about Permitted colors BSE Microbiological content,LOW ACID/ACIDIFIED FOODS,FCE Food Canning Establishment Number Container Dimensions for jars, cans and pouches. SID Schedule Identifier Number,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),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,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