BROKERS ASSOCIATION SEMINAR SPECIAL PRODUCT REQUIREMENTS

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BROKERS ASSOCIATIONSEMINARSPECIAL PRODUCT
REQUIREMENTS

• January 22, 2009
• Chicago District/FDA

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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

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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/

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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/

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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/

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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

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Non-Medical Devices That Emit Radiation

• ACC Accession number from manufacturer
• 2877 Form RAA, RAB , RAC, RAD
• MDL Model Number

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Devices Sunglasses or Reading Glasses

• DEV Registration number for Importer
• LST Medical Device Listing Number
• IRC Impact Resistance Lens Certificate

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Regulations (CFR)

• Use this code plus the qualifier to inform FDA
  that a product is exempted. Most of FDAs
  regulations are in Title 21.

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Biological Products

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

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Biologic Numbers

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

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Susan Ciani, Investigator

• Cosmetics
• LACF/AF Low Acid Canned Foods and Acidified
  Foods
• IFE Import For Export

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Cosmetics

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

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LOW ACID/ACIDIFIED FOODS

• FCE Food Canning Establishment
• Number
• Container Dimensions for jars, cans and pouches.
• SID Schedule Identifier Number

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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)

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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

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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)

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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.