U.S. FDA Agents: What you need to know
What is an FDA Agent?
An FDA agent is the primary point of contact between the FDA and a medical device company.
Their roles include:
Reviewing, disseminating, routing, and responding to all communications from FDA including emergency communications;
Responding to questions concerning those drugs that are imported or offered for import to the United States;
Assisting FDA in scheduling inspections
If FDA is unable to contact a foreign registrant directly or expeditiously, FDA may provide the information and/or documents to the United States agent. FDA's providing information and/or documents to the United States agent is equivalent to providing the same information and/or documents to the foreign registrant.
Why do you need a registered agent?
Assigning a registered agent is required for any medical device company that is engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States.
But how do you choose the right one?
It's not enough to hire someone who can maintain basic correspondence. Ideally, the registered agent will have a deep understanding of regulatory laws in order for your company to remain compliant with FDA standards.
What Zi-Medical can do for you
In addition to being your FDA agent, we have years of regulatory experience to assist you in FDA medical device registration, testing, and global distribution. At Zi-Medical we are equipped with the expertise to help you every step of the way, no matter where you are in the process of registering your medical device.
For more information go to www.fda.gov or if you would be interested in working with us or just have a few questions, don't hesitate. Contact us here: