Registration is not approval
For most product categories, FDA registration refers to registering the facility that makes or handles the product, often paired with listing the products made there. It does not mean the agency has reviewed or approved the product, and suggesting otherwise on labels or in marketing can create its own problems. Some products need actual premarket review, such as new drugs and many medical devices, and that is a separate process with its own requirements. The FDA does not issue registration certificates, and documents sold under that name by private companies are not agency approvals. Sorting out which of these steps applies to your product is where FDA product registration planning begins.
How the rules differ by category
Food facilities register with the FDA and must renew on a set cycle, and foreign facilities need a United States agent. Drug establishments register and list their products, which ties into the national drug code system. Device establishments generally register every year and list their devices, and many pay an annual fee to do so. Cosmetics facilities and products now have registration and listing duties as well under a more recent law. Importers should expect the information they give customs and the FDA at entry to match these filings, because mismatches can lead to shipments being held.
Getting it right for your product
We start by identifying what the product is in regulatory terms, since a supplement, a cosmetic, and a drug can look similar on a shelf and be treated very differently. Then we look at who makes it, where, and under whose name it is sold, because those facts decide who registers and who lists. If a registration already exists, we check whether the information is current and whether the claims on your label and website fit the category. For foreign manufacturers, we discuss the U.S. agent role and the importer's responsibilities. The goal is accurate filings and marketing that does not overstate what the FDA has done.
