Any business outside the US involved in manufacturing, packaging, proliferation, compounding, or processing of any medical device imported into the US shall appoint its US agent.

Responsibilities of US agent

The US. agent may be a resident or business owner in the US, however, must not use a post office box address. Additionally, the US agent must not use an answering machine only and must be available to answer calls directly or through an employee during normal business hours.

The responsibilities of US agent are limited to the followings: 

Support communication between the US FDA and overseas business 

Respond to questions regarding products from overseas business imported or proposed for import into the US

Assist in scheduling of overseas business review 

When the US FDA is unable to directly contact an overseas business, any information or document to be delivered may be sent to the US agent. This is considered as if the information or document was directly sent to the business.

Pursuant to the Medical Device Notification Regulations (21 CFR Part 803), the US agent is not liable for medical malpractice or 510(k); obligation of pre-marketing notification process (21 CFR Part 807, Subpart E).