Mon - Fri: 9:00 am EST - 06:00 pm EST
E & E Medicals: FDA, ISO, Licensing & Compliance, Mark Approval, QA, Medical Supplies and ConsultingE & E Medicals: FDA, ISO, Licensing & Compliance, Mark Approval, QA, Medical Supplies and ConsultingE & E Medicals: FDA, ISO, Licensing & Compliance, Mark Approval, QA, Medical Supplies and Consulting
(Mon - Fri)
info@eemedicals.com
Atlanta, GA 30339
E & E Medicals: FDA, ISO, Licensing & Compliance, Mark Approval, QA, Medical Supplies and ConsultingE & E Medicals: FDA, ISO, Licensing & Compliance, Mark Approval, QA, Medical Supplies and ConsultingE & E Medicals: FDA, ISO, Licensing & Compliance, Mark Approval, QA, Medical Supplies and Consulting

FDA US Agents for Foreign Establishments

US Agent for Foreign Establishments

usa

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 FDA US Agent. An appointed FDA US Agent 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.

We shall function as your FDA US Agent at a reasonable annual fee.
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