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.

Leave a Reply

Fill in your details below or click an icon to log in: Logo

You are commenting using your account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s