What is required?
Becoming a medical device manufacturer in the United States requires that your establishment register with the FDA (Food and Drug Administration). Click here to see the FDA’s requirements for who must register. In addition, your registration information must be renewed annually. If you operate a company outside of the U.S., you must name a U.S. agent on your establishment record with the U.S. FDA.
Where can I get help?
The registration process can be complicated. DP can apply decades of experience and extensive expertise to assist you with the FDA registration process at a competitive rate. By enlisting this service your company will have the assurance that the FDA Registration process is completed correctly. You will receive a certificate verifying that the registration or renewal has been completed for the applicable year. If your company is based outside of the U.S., the DP team can also serve as the U.S. agent.
When do I need to act?
If you need to register with the FDA for the first time, start now! But if you need to renew your registration, the renewal season begins in October of each year. Contact us to request this service on a one-time basis, or to entrust your ongoing annual renewals to the DP Distribution & Consulting ® experts. We can be reached via the form or at 804-965-3981.
Click here to see the other services that DP has to offer.