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US FDA Agent & Official Correspondent

A US Agent is required by the Federal Drug Administration (FDA) when a foreign establishment is involved in the manufacture, preparation, or processing of a device that is imported into the United States. The US Agent must reside in the United States and be available to answer questions from the FDA during business hours. Obelis acts as your US Agent and Official Correspondent and we ensure your products meet the regulatory

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US FDA Agent

Assisting the FDA in communications with the foreign company (including receiving documents directed at the company).
Responding to questions concerning the foreign company’s devices.
Assisting the FDA in scheduling inspections of the foreign company.

Appoint Obelis as your US Agent

Official Correspondent

Manage FDA registration and device listing via the FURLS system
Ensure annual renewal of FDA establishment registration
Act as the primary contact for FDA communications on registration and listing compliance

Appoint Obelis as your Official Correspondent

Obelis FDA Service Package

FDA regulatory submissions (510k, PMA, De novo)

Most medical devices require approval from FDA before they can be legally marketed in the US.
The main approval types are: 510(k) clearance, Pre-market approval (PMA), De novo. The applicable type depends on the device class and status.
Regulatory submissions require the preparation of a dossier for evaluation by FDA. Uncomplete submissions may cause significant delays and extra costs for the manufacturer.