Foods, dietary supplements, medical devices, and drug products all require FDA registrations. There is also an optional cosmetics registration. Additionally, for drugs and devices, the Food and Drug Administration (FDA) requires product listings for each unique product.
Finally, companies must keep their product registration current, or else lose the right to sell or import in the U.S.
Drug Facility Registration –All drug manufacturers, repackers, relabelers, and salvagers are required to register each facility. This includes any foreign facilities that offer drugs for import into the U.S. Additionally, foreign facilities need to identify each U.S. importer.
Drug Listing – Each drug facility that is required to register must also list each drug that it manufactures, repacks, relabels, or salvages for commercial distribution. 21 C.F.R. § 207.41. Drug listings include label proofs and are public. See at Daily Med.
NDC Code – The National Drug Code is a code unique to each drug and is required to be listed.
Labeler Code – A code assigned to each registrant, which is the first part of the required NDC code. It is used to identify the manufacturer of the drug.
Device Facility Registration –A registration for medical device facilities. Any company that manufactures, prepares, propagates, compounds, assembles, or processes medical devices must register each facility. This includes any foreign facilities that offer devices for import into the U.S.
Initial Importer – Any importer that furthers the marketing of an imported device and makes the final sale or delivers to the consumer. Initial importers are required to register and pay the Annual Establishment Registration Fee.
Device Listing – Each device facility that is required to register must individually list each device that it manufactures, prepares, propagates, compounds, assembles, or processes for commercial distribution.
Annual Establishment Registration Fee – An annual fee required for all establishments. In 2019, the fee is $4,884 and for 2020 it will be $5,236.
Food Facility Registration – A registration required for every facility that manufactures, processes, packs, or holds food for consumption in the U.S. This includes manufacturers, processors, packers, or holder of food ingredients and dietary supplements. For foreign foods and supplements, only the last foreign entity to manufacture, process, or pack outside of the U.S. is required to register. Renewals are every other year (even years).
This registration requirement does not apply to farms, retail food establishments, restaurants, soup kitchens or similar, fishing vessels, or non-profits that prepare and/or serve directly to consumers.
United States Agent – All foreign establishments must designate an Agent that resides in or has a place of business in the U.S.
We can help you identify your needs and, if necessary, file your registration. Many companies can file their own registrations, but have questions that the FDA simply does not answer. Examples include which foreign facilities need to be registered, or explaining how to get a labeler code or DUNS number.
Other companies just need a U.S. Agent that can also take on the FDA in the case of an enforcement action. Whatever your needs, we can help. Whether you need assistance with filing, guidance for your team, or representation of your interests, we will be there for you.
Take the first step to freedom and schedule a call with us today.