Your US agent is the communication intermediary between you and the US government. The US agent has many responsibilities including
- being responsible for initial handling of complaints,
- submissions of Medical Device Reports (MDRs),
- 510(k) submissions,
- submissions for Pre-market Approval,
- correction and removal reports,
- radiological product reports,
- reports to the FDA within ten working days of any correction or removal of a device initiated to reduce a risk to health.