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.
Official Correspondent
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Manage FDA registration and device listing via the FURLS system
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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.
- Obelis can offer expert support in preparing and submitting regulatory dossiers that meet FDA expectations.
UDI registration in GUDID database
Classification support
Label review
Averse events reporting
We can help you in other markets too
Why Obelis?
With more than 35 years of global experience in regulatory requirements for medical devices, we can assist your company in accessing the U.S. market hassle-free. Get in touch today to find out more.