The Code of Federal Regulations, specifically 21 CFR § 207.69, requires all domestic and foreign companies to have an official contact located in the US in order to act as the primary contact with the FDA and liaise between the FDA and the sponsor company for all communications. Specifically for non-US (foreign) entities, any company that wishes to register a new medicine or device with the FDA must appoint a US agent, as must foreign companies that wish to import medicines during the registration process.
The responsibilities of the US agent include:
- assisting FDA in communications with the foreign establishment(s),
- responding to questions concerning importation (imported or offered for import into the US),
- assisting FDA in scheduling inspections of the foreign establishment(s) and
- receiving information and/or documents directly from FDA when the Agency is unable to contact the foreign establishment directly or expeditiously.
During the drug registration process, the foreign company must provide a letter of appointment to be included in the application. The US agent then acts as the direct point of contact for all FDA communications as well as acting as the signatory for submission documents including the necessary registration forms.
By regulation, the US agent is not responsible for the reporting of adverse events under the Medical Device Reporting requirements (21 CFR § 803) or for submitting 510(k) Premarket Notifications (21 CFR § 807, Subpart E).
Boyds can act as a trusted US agent to engage the FDA for all inquiries, meeting requests and scheduling, facilitation and compilation of submissions, as well as emergency notifications. Boyds has deep expertise in regulatory affairs and drug development and is uniquely placed to support all drug and device registration needs. With offices globally in the EU, the UK, and the US, we can provide seamless services for all establishments.
For further information and assistance, please contact a member of the team.