As part of FDA’s Medical Device Registration and Listing requirements pertaining to medical device approval, medical device and IVD companies outside the United States must appoint a registered U.S. FDA Agent. The U.S. FDA Agent must be a resident of the United States or maintain a physical place of business in the United States. The U.S. Agent serves as a liaison between your company and the FDA.
The responsibilities of the U.S. agent include:
- Assisting FDA in communications with the foreign establishment;
- Responding to questions concerning the foreign establishment’s devices that are imported or offered for import into 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 considered to be equivalent to providing the same information or documents to the foreign establishment.
Some companies opt to hire a distributor instead of a professional regulatory firm; however, this may not be in the best interest of your company. Distributors are in the business of selling your products and are usually not experts in regulatory matters. Will the distributor know how to handle a situation when contacted by the FDA? What happens if your company has to switch distributors? A professional regulatory firm such as AlvaMed has the experience and expertise when it comes to dealing with matters with the FDA.
Since 2002, AlvaMed has helped numerous medical device companies with all facets of the medical device business including acting as the U.S. FDA agent for companies outside the United States. AlvaMed’s team provides a professional, knowledgeable, and prompt response to inquiries from the FDA; always acting in the company’s best interest.
AlvaMed charges a nominal fee to act as the U.S. FDA agent for your company. Any needed regulatory support related to the responsibilities written above are billed on a time and materials hourly basis; the time and cost of the regulatory support is approved by the client before any work begins. If your company is interested in having AlvaMed act as your U.S. FDA agent, please contact AlvaMed for support.