Below are the requirements for filing entries with The Food and Drug Administration (FDA)
The Food and Drug Administration (FDA) regulates the importation of:
- Human food and food ingredients (including wild game used for food)
- Animal feed and animal feed ingredients
- Human and animal drugs (anything, components of anything used for or intended for diagnosis, prevention, treatment or cure of disease)
- Medical devices
- Human biological products (blood, blood by products, antitoxins, vaccines, therapeutic serum)
- Human cosmetics and components
- Food service containers
- Radiation emitting products
Examples of products:
Antibiotics Bulk & finished dosage forms of drugs Antitoxins, Enzymes, VenomsIn-Vitro Diagnostic Products Blood/Blood DerivativesIn-Vivo Diagnostic Products Prescription DrugsVaccines Non-prescription
By-products for feed (meal, corn cobs, etc.)Pet Foods (cat, bird, dog, horse, fish, etc.) Drugs Silage for feed (medicated & non-medicated)
Diagnostic Devices, Medical Devices
Cathode Tubes, Therapeutic Ultra-sound Equipment, Infra-red lights(infrasonic, sonic), Lasers, Ultra-violet lamps (sun lamps), Microwave Ovens, Video (TV's, monitors, cathode ray tubes, X-ray units & Components, oscilloscopes, TV projection systems)(film, testing systems)
General Importing Information
The U.S Food & Drug Administration regulates the entry of all products that pose a potential health risk to U.S Consumers. These products include food, medications, medical devices, drugs, cosmetics and radiation emitting devices. For specific information on product requirements and regulations please visit FDA's website.
The following information is provided as a service to our clients and is subject to change as FDA regulations are amended.
In order for Portside Customs Service, Inc. to process your shipments in a timely manner the following information MUST be clearly indicated on your Customs Invoice:
- a complete accurate description of the commodity that is being shipped ( Example: "surgical hand instrument" is not an accurate description, "scalpel" is).
- the quantity of the product being shipped (4 pallets of canned peaches is not acceptable, 4 pallets each containing 22 boxes each box containing 12 - 10 oz glass jars is)
- information on the packaging and shipping method ("coffee" does not indicate to us if the coffee is in burlap bags, metal tins or plastic pouches; is the commodity being shipped frozen, refrigerated or at room temperature)
- the manufacturer of the product - in order for FDA to verify that the product is listed with FDA we must report the complete name and address of the manufacturer of the commodity
- the FDA Registration of the manufacturer, and shipper (if different).
Providing any known FDA registration numbers may aid the FDA in verifying the admissibility of the product. Examples of FDA registration numbers include:
- National Drug Code #'s (NDC) for medications
- Investigational New Drug #'s (IND) for medications under development
- Establishment Registration Number (for manufacturer or distributor of FDA regulated goods)
- Medical Device Listing #
- Premarket Approval Number (510K#)
- Accession # for radiological devices
- New Animal Drug Application # (NADA)
- Food Canning Establishment # (FCE) for low acid canned foods Providing as much information as possible is necessary for PBB to properly classify FDA regulated goods. Detailed descriptions also make it easier for the FDA to determine the admissibility of your goods. All of this will lead to quicker processing times at the Port of Entry and help to avoid costly delays.
Portside Customs Service, Inc is capable of reporting the information to the FDA electronically through the Operational and Administrative System for Import Support (OASIS) program, thereby decreasing the waiting time at the point of importation and increasing the number of "May Proceed" notices.
OASIS has significantly speeded up the time within which FDA makes its admissibility determinations for imported products. Under the legacy manual system, FDA's review processes took days; OASIS routes electronic admissibility decisions to 2200 importers agents' PCs within minutes after their shipment data is transmitted electronically to FDA. With OASIS, 85% of the shipments are cleared without any submission of paper by the importers, versus the previous requirement for submission of paper documentation for all shipments
In order for entries to be processed through the OASIS program at the time of entry (release) we must have the following information for each shipped product subject to FDA regulation.
- Actual FDA Manufacturer
- FDA Shipper
- FDA Country of Origin
- FDA Product Code (we can determine this for a one time set up fee per commodity)
- FDA Description
- FDA Value
- FDA Consignee Name/Address and IRS number
- FD 2877 for Radiation Emitting Devices
- Accession Number (for radiation emitting devices)
- FCC 740 if it is an electronic device (required for radiation emitting devices)
FDA Product Code Builder (allows you to proper classify your goods for FDA to avoid any confusion at time of entry, it is strongly recommended that you go through the tutorial before classifying your goods):