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FDA Consulting and Licensing

Ferguson Medical International is dedicated to the successful commercialization of new medical devices within the US market. Over the past 30 years, we have successfully obtained hundreds of 510(k) clearances on behalf of device firms worldwide.

Our Services Include:

  • 510(k) Submission (Pre-Market Notification)
  • 513g Submissions for Classification Ruling
  • Unique Device Identification (UDI) Compliance
  • FDA Pre-Submission Meetings
  • IDE (Investigational Device Exemption)
  • PMA (Pre-Market Approval)
  • United States Agent/Official Correspondent Services