US Agent (FDA US Agent)

In adverse events under the Medical Device Reporting regulation (21 CFR Part 803) or submitting 510(k) Premarket Notifications (21 CFR Part 807, Subpart E), the United States Food and Drug Administration (FDA) requires all medical devices, IVD, and pharmaceutical companies not located (foreign facility) in the United States to appoint a registered US FDA Agent. An appointed FDA US Agents must be a resident of the United States OR maintain a place of business in the US. Each foreign establishment may designate only one U.S. agent. The foreign establishment should provide the name, address, telephone and fax numbers, and e-mail address of the U.S. agent. The US agent is not responsible for reporting

  • E & E Medicals and Consulting Assist FDA in communications with foreign establishments
  • E & E Medicals and Consulting Assist in scheduling inspections of the foreign establishment’s Facility