What is the FEI number for pharmaceutical companies? How can one apply for the FEI number of the FDA and the Registration number for FDA registration?

　　The Food and Drug Administration (FDA) is one of the executive agencies established by the United States government within the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). As a scientific management agency, the FDA's responsibility is to ensure the safety of food, cosmetics, drugs, biological products, medical devices, and radiological products produced in the United States. It is one of the earliest federal agencies that prioritize protecting consumers.

　　1. What is an FEI number?

　　According to Section 510 of the Federal Food, Drug, and Cosmetic Act and 21 CFR part 207, all enterprises engaged in the production, preparation, transportation, and processing of drugs need to register (establishment registration) and submit information on all products already on the market (drug listing). After submitting establishment registration, the FDA will assign an FEI number to the enterprise.

　　There are two ways to abbreviate FEI. One is FDA Establishment Identification (see FDA website: https://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/ucm393190.htm);

　　The other is Facility Establishment Identifier (see FDA guidance: Self-Identification of Generic Drug Facilities, Sites, and Organizations Guidance for Industry);

　　In summary, the FEI number is issued by the FDA to enterprises, facilitating the FDA's supervision and various inspections of the enterprises. In addition, the FDA also uses this FEI number to trace whether the enterprise has timely paid the Drug Establishment Fee.

　　2. Establishment registration registration materials

　　This establishment registration, also known as Facility Establishment registration or drug establishment registration; after submitting the establishment registration materials and passing the verification, the FDA will issue an FEI number to the enterprise. The FDA office responsible for establishment registration is the Commissioner's Office. Therefore, the application for the FEI number, that is, submitting the establishment registration materials (electronically), before January 1, 2009, the application for the FEI number could be submitted in paper form. After January 1, 2009, the FDA only accepts electronic submission. From then on, the application materials are submitted once a year.

　　File format: XML format SPL file

　　The FDA provides two tools for creating SPL files: CDER Direct and Xform. SPL files created by Xforms or third-party software need to be submitted through the FDA WebTrader (that is, Electronic Submissions Gateway) account. After submitting the registration and listing materials, both need to be verified by the official verification software. The FDA has a system that can automatically identify whether each item filled in the SPL file complies with the regulations. If there are any errors in the filling, it will fail the verification. This improves efficiency and reduces the workload of FDA staff.

　　The contents that the SPL file needs to include:

　　The name and address of the manufacturer

　　All trade names used by the manufacturer

　　All types of ownership (individual, partnership, company) of the manufacturer

　　The owner or operator of the manufacturer

　　For overseas manufacturers, additional information is required:

　　The name, address, and phone number of the US agent structure;

　　The name of the exporter;

　　If previously registered for other plants, in the SPL file, the following information of the previously registered plants needs to be included:

　　Official contact person, email, phone number, and mailing address;

　　What each plant is used for;

　　In addition, the DUNS number (Dun & Bradstreet number) needs to be provided in the SPL file; if not, the FDA can arrange for the applicant to obtain the DUNS number.

　　3. References

　　(1) FDA website

　　(2) FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format – Drug Establishment Registration and Drug Listing

　　The FDA certification mainly focuses on products, food, food contact materials, drugs, medical devices, and lasers. The FDA classifies medical devices into categories I, II, and III, with higher categories receiving more supervision.

　　The FDA certification scope: All equipment, materials, etc. that directly contact food and beverages or directly contact the human mouth must pass the FDA certification standard testing and certification before entering the US market?

　　1. FDA inspection and certification of food packaging materials: paper, plastic film, metal, plastic aluminum foil 2. FDA certification for glass ceramic products: Various glass ceramic products such as pots, bowls, plates, spoons, basins, cups, bottles, and kettles;

　　3. FDA certification for food-grade plastic products: Plastic materials that come into contact with food or are directly consumed;

　　4. Food;

　　5. Medical devices;

　　6. Pharmaceuticals;

　　7. Food additives;

　　8. Beverages;

　　9. Materials related to food;

　　10. FDA certification for coating products: Wax copolymers, PVC coatings, powder coatings, inks, etc. applied to food-contact surfaces;

　　11. FDA certification for water and plumbing hardware products: Water pipes, containers, pump valves, water heaters, etc. that come into contact with drinking water or tap water;

　　12. FDA certification for rubber resin products;

　　13. FDA certification for sealing materials;

　　14. FDA certification for chemical additives: Pigments, preservatives, antioxidants, surfactants, etc.

　　For enterprises exporting food, pharmaceuticals, and medical devices to the United States, they must register with FDA, list the enterprise and the products, otherwise the customs will not allow clearance. Therefore, it is a mandatory requirement, similar to the CE in the EU. Confirm the product name, confirm the product category and code, submit the registration application, apply for the PIN code and payment guidelines, pay the annual fee in US dollars, and the US dollar will be credited after the payment. Then register.