US FDA Agent Service for Full FDA Compliance

Our Leading US FDA Agent Service

Under the stringent regulations of the United States Food and Drug Administration (FDA), foreign establishments engaged in the manufacturing, preparation, propagation, compounding, or processing of imported devices must designate a US-based US FDA Agent.

Over the last 25+ years, MedEnvoy Global’s executive management has been an FDA registered medical device US agent for 500+ overseas medical device companies.

The US Agent must be based in the US, with a physical location, and must be readily available to the FDA during standard business hours. Our central office in Austin, Texas, ensures seamless communication with both your company and the FDA.

As your US FDA Agent, we will:

• Facilitating FDA communication with non-US-based manufacturers.
• Providing swift responses to queries about your foreign establishment’s devices intended for import into the US.
• Assisting the FDA in scheduling inspections of your foreign establishment. In cases where direct contact with the foreign establishment is impractical, the FDA may convey information or documents to the US Agent, effectively serving as notice to the foreign establishment.

Please note that the US Agent has no responsibility related to reporting of adverse events under the Medical Device Reporting regulation or submitting 510(k) Premarket Notifications.

Your FDA Official Correspondent

Our FDA Official Correspondent service is focused on engaging with the FDA concerning your establishment registration and device listing information.

The Official Correspondent is not constrained to the US and can be a representative of your company, regardless of your company’s location. However, some foreign establishments opt to appoint their selected US FDA Agent as their Official Correspondent, ensuring they are the primary point of contact for FDA interactions.

FDA Establishment and Medical Device Registration Support

If you are involved in the creation, importation, reprocessing/rebranding, or specification development for medical devices or IVDs intended for commercial sale in the US, annual registration with the FDA is mandatory. This process, known as “Establishment Registration,” is distinct from device clearances or approvals.

As your partner for US FDA Agent services, Medical Device Registrations, and FDA Establishment Registration, we uphold the highest service standards to ensure your regulatory compliance.