FDA U.S. Agent

ACCURATE CONSULTANTS CAN SERVE AS YOUR US AGENT FOR MEDICAL DEVICES AND DRUGS

Registration & Listing for Medical Devices: $495 Annual, Fixed fee

Drug Registration Listing Services: Will provide Proposal Based on # of Products

The United States (US) Food and Drug Administration (FDA) requires that all non-US based Medical Device and IVD companies must appoint a registered US Agent, who must be a resident or maintain a physical place of business in the US.

As your US Agent, we will serve as a liaison between your company and the FDA and ensure all US regulations are met by keeping up with any changes in the regulatory environment. For Drug Registration we are familiar with the CDERDirect portal and can manage the entire process from end to end without involving other outside parties.

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Click the link below to see information from FDA on U.S. Agent responsibilities which are summarized below [Link].

All foreign establishments must notify FDA of the name, address and phone number of their U.S. Agent. The U.S. Agent must either reside in the U.S. or maintain a place of business in the U.S. and must be available to answer the phone during normal U.S. business hours.

The responsibilities of the U.S. agent are as follows:

1. 1. Assisting FDA in communications with the foreign establishment;
   2. Responding to questions concerning the foreign establishment’s products that are sold in the United States;
   3. Assisting FDA in scheduling inspections of the foreign establishment; and.
   4. If FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be equivalent to providing the same information or documents to the foreign establishment.

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Should you need additional services, Accurate can provide regulatory, testing, preclinical, clinical, and compliance services to meet FDA requirements for 510(k)s, PMAs and IDEs. These services include, but are not limited to: FDA annual establishment registration and device listing, official correspondent responsibilities, resolution of import issues, regulatory strategy, required biological and/or functional testing, clinical study design and conduct, quality systems development and implementation, and writing regulatory submissions.