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1、BROKERS ASSOCIATIONSEMINARSPECIAL PRODUCT REQUIREMENTSJanuary 22, 2021Chicago District/FDARyan Gibson, InvestigatornHuman DrugsnAnimal DrugsnMedical DevicesnMedical Devices That Emit RadiationnNon-Medical Devices That Emit RadiationnDevices: Sunglasses/Reading GlassesnRegulationsnBiological Products
2、nBiological NumbersHuman DrugsnDLS Drug Listing Number from the Foreign ManufacturernNDA New Drug Application from the n U.S. FirmnIND Investigation New DrugnANDA Abbreviated New Drug Application n :/ANIMAL DRUGSnNAD New Animal Drug ApplicationnNumber Number issued by FDA/CVM to an U.S. Firm/Sponsor
3、nANA Abbreviated New Animal DrugnNumber Number issued by FDA/CVM to a nU.S. Firm/SponsornDLS Drug Listing Number from the Foreign Manufacturer nINA Investigational New Animal Drugn :/MEDICAL DEVICESn DEV Registration number for Importern LST Medical Device Listing Number n PMN Premarket Notification
4、 (510(k)#)n PMA Premarket Approval (“P#)n IDE - Investigational Device Exemptionn :/Medical Devices That Emit RadiationnDEV Registration Number For ImporternLST Medical Device Listing Number nPMN 510 (k) NumbernACC Accession numbern2877 Form 4 parts to the form A, B, C, DNon-Medical Devices That Emi
5、t RadiationnACC Accession number from manufacturern2877 Form RAA, RAB , RAC, RADnMDL Model Number Devices Sunglasses or Reading GlassesnDEV Registration number for ImporternLST Medical Device Listing Number nIRC Impact Resistance Lens CertificateRegulations (CFR)nUse this code plus the qualifier to
6、inform FDA that a product is exempted. Most of FDAs regulations are in Title 21.Biological ProductsnBFL Biological Establishment License Number nBPL-Biologic Product NumberBiological License Number can be provided using either AofCBiologic NumbersnBiologic 510(k) BK960002 Use Device AofC PMNnBiologi
7、c PMA BP000028 Use Device AofC PMAnNDA BN 040083Use Drug AofC NDA Susan Ciani, InvestigatornCosmeticsnLACF/AF: Low Acid Canned Foods and Acidified FoodsnIFE: Import For ExportCosmeticsnIf it is a drug, it requires foreign DLS.nConcerns about nPermitted colorsnBSEnMicrobiological contentLOW ACID/ACID
8、IFIED FOODSnFCE Food Canning Establishment NumbernContainer Dimensions for jars, cans and pouches.nSID Schedule Identifier Number LOW ACID/ACIDIFIED FOODS PRODUCT CODING CONSIDERATIONSnSubclass is important to identifying products subject to LACF RegulationsProducts that are not hermetically sealed
9、are exempt from LACF RegulationsnSubclass E (Metal), C (Glass), V (Vacuum or Modified Atmosphere Packgaing)LOW ACID/ACIDIFIED FOODS PRODUCT CODING CONSIDERATIONSnPIC is important to determining which products are subject to LACF RegulationsnPIC E Commercially Sterile: Product is packed in hermetical
10、ly sealed container and heat treated to achieve commercial sterilitynPIC I Acidified: Low Acid Foods that are hermetically sealed to which acid is addedLOW ACID/ACIDIFIED FOODS PRODUCT CODING CONSIDERATIONSnExamplesnCanned Tuna/Commercially Sterile16AEE45/Fish/ Metal / Commercially Sterile / Tuna (A
11、lbacore, Yellowfin, Bluefin, Skipjack, Etc.)nCanned Artichokes/Acidified24TEI01Leaf / Stem Veg/ Metal / Acidified / Artichoke (Leaf & Stem Vegetable) Import for ExportnProduct will be imported into the U.S. but will be exported.nDoes not require a qualifier.nAllows for importation of violative articles.
