Any manufacturer or importer intending to import a medical device into the United States requires a US FDA Agent, if there is no presence of company in the United States.
Pre-Requisites/Qualifications to Act as the US FDA Agent
As a prerequisite for providing the US FDA Agent Services, he/she must be a resident of the United States or have a physical place of business in the U.S. with an active DUNS number.
Foreign manufacturers must designate a US Agent to carry out establishment registration, device listing, and other activities, which must be completed prior to importing the device to the US. In the case of the 510(k) exempted Class I and II devices, the US Agent can be appointed right away, followed by an establishment registration, device listing, and importation into the US.
For Class I and II devices without 510(k) exemption and a few Class III devices subjected to premarket notification, shall be 510(k) cleared before appointing the US agent and carrying out the establishment registration and device listing activities. Likewise, a few Class II devices and III devices subjected to premarket approval must secure Premarket Approval (PMA), post which they can appoint an agent. The same would apply to other devices opting for De-Novo, IDE, and HDE submissions.
Primary responsibilities of a U.S. Agent
- Assisting the FDA in communications with your company
- Responding to the queries related to the imported products sold in the U.S.
- Helping the FDA in scheduling the inspections to your facilities
- As your U.S. Agent, Freyr serves as a liaison between your company and the FDA
- Assistance in compliance with FDA norms
- Expert And dedicated team to handle your Regulatory responsibilities
- Provision of single source for representation in all the markets
- In case the US FDA is unable to contact you directly, then any document or information provided by the US FDA will be considered equivalent to providing the same information or documents to your company
- Cost-effective annual support for US Agent Service
- Ensured Regulatory expertise outlook
- Qualified team of experts with hands-on experience across all categories of Medical Devices
- Extensive partner network across U.S.