Importing Medical Devices Into the U.S.: What The FDA Checks at the Border
The short version When a medical device arrives at a U.S. port, The FDA checks four things: that the firms involved are registered and the device is listed, that any required 510(k) or PMA is in place, that the manufacturer or product is not on an Import Alert, and that the device holds up to…
What Does a U.S. Agent Service Include? A 2026 Price and Scope Comparison
By Wyatt Sage, FDA Entry Point | Published October 8, 2026 | Last updated October 8, 2026 Short answer: A U.S. Agent is the person or company in the United States that The FDA can contact on behalf of a foreign facility. Providers bundle very different things under the same name, so prices and scope…
FDA Food Facility Registration Renewal 2026: The Window Is Now Open
The FDA food facility registration renewal window opened October 1, 2026 and closes December 31, 2026. Every food facility that is required to register must renew in this window. The FDA will consider the registration of any facility that does not renew by December 31, 2026 to be expired. Registration renewal happens every two years,…
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…
What Makes a Good U.S. FDA Agent (And What to Watch Out For)
If you’re a foreign manufacturer selling into the U.S., you already know you need a U.S. Agent. It’s not optional, FDA requires it for food, drug, cosmetic, and medical device facilities based outside the country. What a lot of companies don’t realize until they’re already signed up is that “U.S. Agent” isn’t a standardized service.…
Adverse Event Reporting and Recordkeeping Under MoCRA: What You Actually Have to Do
If someone has a bad reaction to your cosmetic product and reports it to you, you now have a legal clock running. Since December 29, 2023, MoCRA (the Modernization of Cosmetics Regulation Act of 2022) has required cosmetics companies to report serious adverse events to FDA, and to keep records of every adverse event they…
When Does a Cosmetic Become a Drug?
If you sell a cream, serum, or shampoo into the U.S. market, the ingredients aren’t what decide whether FDA treats your product as a cosmetic or a drug. The claims you make about it do. This is a very important factor to consider. You could be looking at an unapproved drug on the market, a…
How to Import Food Into the US: A Step-by-Step Guide
Importing food into the United States is not a single filing. It is a chain of separate requirements, run by two different federal agencies, that all have to be satisfied before your shipment reaches a store shelf. Miss one link and FDA can hold your product at the port, no matter how good the product…
Responsible Person vs. U.S. Agent: What Every Cosmetics Company Needs to Know
If you’re bringing a cosmetic product into the United States, you’ve probably run into two terms that sound like they mean the same thing: Responsible Person and U.S. Agent. Mixing them up is one of the most common compliance mistakes we see from international cosmetics brands, and it can leave a gap in your FDA…
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