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
-
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.
- 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