Foreign and domestic facilities that engage in the manufacturing, labelling, packaging, warehousing, or any other operations affecting the quality of the products involving foods, drugs, and medical devices, are mandated to register with the US FDA. Upon FDA registration, each facility is assigned a unique registration number by the FDA, which is used to identify the firm for inspections, examinations, screening of imported products, and other regulatory activities.
This FDA Registration process helps the FDA to promptly locate the source of any issues, such as product contamination, to prevent the further spread or recurrence of the problem. The information required for registration includes the legal name and address as per the DUNS database The specific registration requirements and information needed vary depending on the type of product such as food and nutraceuticals, cosmetics, drugs, and medical devices.
Food Facility Registration
Post September 11, 2001, terrorist attacks, the U.S. Congress passed the Bioterrorism Act of 2002, which requires all food facilities manufacturing food (including food supplements and nutraceuticals) for consumption in the U.S. to register with the FDA. This includes facilities engaged in manufacturing/processing, packing, or holding food for human or animal consumption in the United States, regardless of whether the food remains within the state or enters interstate commerce. The following information is required for Food facility registration.
· Name of the manufacturer
· Address of the manufacturer
· Contact person and designation.
· Contact number and email.
· DUNS number
· Category of food products
The average time required for food facility registration and listing timeline is 1-2 working days.
Drug Establishment Registration
All the drug establishments – foreign and domestic must register their establishments and list all their drug products that are in commercial distribution in the USA. Drug establishment registration and listing are required for new/investigational drugs, generic/OTC/homoeopathic drugs, facilities like drug testing, sterilization, etc.
· Address of the manufacturer
· DUNS number
· Contact person and designation.
· Contact number and email.
· Drug name / API name.
· Label compliance.
· Labeler code
· NDC application
· Drug Listing
The average time required for drug establishment registration and listing timeline is 10-12 working days.
Medical Device Establishment Registration
Establishments involved in the manufacturing, exporting, importing and distribution of medical devices intended for use in the USA must annually register the establishment with the FDA, a process known as medical device establishment registration (Title 21 CFR Part 807).
· Address of the manufacturer
· DUNS number
· Contact person and designation.
· Contact number and email.
· Medical Device name
· Device FDA Code
· Device Regulation Number
· Label compliance.
· Device Listing
The average time required for medical device establishment registration and listing timeline is 3-6 working days.
Cosmetic Facility Registration
Cosmetic product manufacturers and processors must complete the Cosmetic Facility registration with the FDA and renew their registration every two years. A responsible person (i.e., the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product) must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually.
· DUNS number
· Contact person and designation.
· Contact number and email.
· Application for FEI
· Cosmetic device name
· Cosmetic Registration
· Cosmetic Listing
· Cosmetic label review
The average time required for cosmetic establishment registration and listing timeline is 10-12 working days.
Conclusion
Foreign manufacturers and exporters always must appoint a reputed US Agent to complete the FDA registration and listing. Contact the I3CGLOBAL team of regulatory experts for proper guidance.
