Tag: us-imports
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,…
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…
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.
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.