FDA Registration

The FDA (Food and Drug Administration) regulates food, pharmaceutical, cosmetic, and medical device products in the US to ensure consumer safety.

Businesses in these fields need to register and comply with FDA requirements for their products to be legally sold in the US market.

Why use this service at AWE Global?

Process

Documents / information needed

• Detailed product information
• Manufacturing/packaging facility information
• Labeling and product ingredients (if applicable)

The FDA regulates a very wide range of products — from food and cosmetics to medical devices — so determining whether your product falls under its scope is the crucial first step before exporting to the US market.

Common mistakes to avoid

• Assuming every consumer product needs FDA registration, when only specific categories actually fall under its scope.
• Overlooking labeling and ingredient requirements under FDA standards, causing goods to be held at customs.
• Not renewing the facility registration on the required cycle (usually every 2 years), invalidating the registration.

Frequently asked questions