US agent for non-US food, drugs & medical device manufacturers

Your US agent is the communication intermediary between you and the US government. The US agent has many responsibilities including

  1. being responsible for initial handling of complaints,
  2. submissions of Medical Device Reports (MDRs),
  3. 510(k) submissions,
  4. submissions for Pre-market Approval,
  5. correction and removal reports,
  6. radiological product reports,
  7. reports to the FDA within ten working days of any correction or removal of a device initiated to reduce a risk to health.

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