Category: Industry News
What Does an FDA U.S. Agent Service Include? A 2026 Price and Scope Comparison
“What do we actually get for the annual agent fee?” It’s a fair question, and it’s a harder one to answer than it should be. The FDA U.S. Agent market ranges from $99 a year to $2,500 a year, and that range doesn’t reflect one service sold at different prices. It reflects several different services…
End-of-Year FDA Agent Checklist: What International Companies Must Review Before the New Year
As the year comes to a close, foreign manufacturers and exporters selling products into the United States should take time to review their FDA compliance status—especially their U.S. FDA Agent designation. For international companies, an FDA agent is not optional. It is a legal requirement for most FDA-regulated products entering the U.S., including food, dietary supplements, cosmetics, medical devices, and…
Why Every International Manufacturer Needs a U.S. FDA Registered Agent (and How to Choose the Right One)
Your Complete Guide to FDA Registration, U.S. Agent Requirements, and Smooth Importing If your company is located outside the United States and you want to sell food, cosmetics, medical devices, supplements, or pharmaceuticals in the U.S. market, the U.S. Food and Drug Administration (FDA) requires you to appoint a U.S. FDA Registered Agent. This role is not optional—it’s…
Top 10 Questions About FDA Registered Agents — Answered
Use this 8-step FDA compliance checklist to avoid costly shipment delays and ensure your products enter the U.S. smoothly.
Navigating FDA Requirements: Establishment Registration Explained
If your company is based outside of the United States, the FDA has one more requirement during that registration process: you need to name a U.S. Agent.