U.S. FDA Import Requirements by Product Category
FDA import requirements for food, cosmetics, dietary supplements, medical devices, and radiation-emitting products — what to register, notify, and label before you ship.
Food & Beverage
식품 · 음료
The most common and most demanding area of FDA import. Facility registration and shipment-by-shipment Prior No…
Cosmetics
화장품
MoCRA (2022) rewrote cosmetics regulation for the first time in 84 years — facility registration, product list…
Dietary Supplements
건강기능식품
Under DSHEA (1994), dietary supplements are classified as 'food' in the U.S., so there's no FDA premarket appr…
Medical Devices
의료기기
The most complicated of the five categories. Premarket pathways differ completely by risk class (Class I/II/II…
Other (Radiation-Emitting Products, Tobacco, etc.)
기타 (방사선기기 · 담배 등)
Beyond the four categories above, FDA also regulates radiation-emitting electronic products (lasers, microwave…