US FDA Agent
Designate DD Global MedDev as your U.S. Agent
The U.S. Food and Drug Administration (FDA) requires food, medical device, drug, and radiation-emitting device companies located outside of the United States to designate a U.S. Agent when registering with FDA. FDA sends communications to your U.S. Agent regarding inspections and other regulatory matters, which often require an immediate response.
As your U.S. Agent, DD Global MedDev will assist with FDA registration and reporting, provide guidance with FDA requirements for your industry, assist with FDA detentions, monitor your facility’s FDA compliance, and more.
What is a FDA agent?
FDA US Agent – Overview of Responsibilities: A FDA US Agent serves many important roles for a foreign manufacturer or distributor. A FDA US Agent is required for any foreign company – medical device, drug, dietary supplement, food (juice, seafood, canned (acidified) food, conventional food), or animal products.