NAMSA Can Act as Your United States Agent
As part of FDA’s Medical Device Registration and Listing requirements pertaining to medical device approval, organizations outside the United States must designate a FDA U.S. Agent. Click the link below to see information from FDA on U.S. Agent responsibilities.[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:
- Assisting FDA in communications with the foreign establishment;
- Responding to questions concerning the foreign establishment’s products that are sold in the United States;
- Assisting FDA in scheduling inspections of the foreign establishment; and.
- 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.
NAMSA’s U.S. Agent Agreement includes only the above listed U.S. Agent responsibilities.
NOTE: Three (3) hours of regulatory support related to the responsibilities listed above are included with this agreement. Any additional support will be billed on an hourly basis.
The U.S. Agent Agreement is for a period of one year at a fee of $1,500.
Should you need additional services, NAMSA 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.