Medical device compaies that manufacture medical devices imported into the US, including contract manufacturers of finished devices and contract sterilizers, must designate a US Agent and identify this person in the FDA’s registration database. In accordance with the regulations in 21 CFR 807.40, each non-US establishment may designate only one US Agent, who is either a resident of the United States or maintains a place of business in the US.
DLC can provide US Agent services via its company based in the US: Donawa Lifescience, Inc. As your US Agent, Donawa Lifescience, Inc. will be responsible for:
Assisting FDA in communications with your company
Responding to questions concerning your products that are exported or offered for export to the US, and
Assisting FDA in scheduling inspections of your company
Please note that FDA does not require the US Agent to report adverse events under the Medical Device Reporting regulation (21 CFR 803) or submit 510(k) Premarket Notifications on behalf of your company.