The FDA is in the process of finalizing this rule for foreign medical device companies that would require a Designated Agent in the US who would be responsible to maintain the annual registration, device listing updates and provide the FDA with an access to the companies in the US. We have served as the Designated Agent for many of our foreign clients for over 10 years. Providing them 510(k) assistance, importation problem guidance, Complaint investigation and Medical Device Reporting guidance as well as dealing with the FDA for foreign facilities inspections and corresponding to the agency in their behalf.