The U.S. Food and Drug Administration (FDA) protects U.S. public health by ensuring the safety, efficacy, and security of drugs, biological products, medical devices, food, cosmetics, and products that emit radiation. Certain products in the U.S require FDA approval before entering the market, while others are simply subject to FDA regulations for manufacturing, marketing, and distribution.

We hope that these guides will help map out your company’s required regulatory steps, so that you can be confident that you’re in good standing with the FDA.

Please contact us for further FDA compliance questions and support. Business Sweden has external FDA consultant partners in the U.S. and has helped a variety of Swedish food and medical companies enter the U.S. market.

FDA Guides
USA FDA Guide – food
USA FDA Guide – medical devices, drugs and cosmetics
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