Category: FDA Regulations & Updates
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…
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…
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…
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.
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?…
Step-by-Step Guide for Importers Needing to Register a Food Facility with the FDA
If your company manufactures, processes, packs, or holds food intended for U.S. consumers, FDA food facility registration is not optional. Under the Food Safety Modernization Act (FSMA), food from unregistered foreign facilities can be held at the U.S. port of entry, a costly disruption no importer wants to face. Here’s exactly what you need to…
The FDA Just Launched a New Import Resource Hub: Here’s What Every Importer Needs to Know
If you import (or plan to import) products into the United States, the FDA just made your life a little easier. On May 18, 2026, the agency launched a new centralized page: FDA Import Educational Resources. It’s a one-stop hub of videos, quick guides, and organized links covering every stage of the import process. It’s a…