Tag: importing-to-us
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…
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…
FSVP vs. U.S. Agent: What’s the Difference?
FSVP and U.S. Agent are not the same FDA role. Learn the legal difference, who needs each one, and how FDA Entry can help as your U.S. Agent.
Importing Cosmetics into the United States: A Beginner’s Guide for International Brands
This guide walks through the basics: what counts as a cosmetic under U.S. law, what doesn’t need FDA oversight at all, what MoCRA actually requires of you, and how a shipment moves through customs. It’s written for someone doing this for the first time, not for a regulatory specialist.
What Is FDA Prior Notice and Why Does It Matter for Your U.S. Shipment?
If you’re exporting food, beverages, or animal feed to the United States, you’ve likely encountered the term Prior Notice. Missing this requirement, or getting it wrong, can stop your shipment at the border, leading to costly delays and product destruction. Here is what you need to know to keep your cargo moving. What Is Prior Notice?…
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.