US Agent Services

Regulatory Services include:

Obelis’ US Agent

All device manufacturers must identify an Official Correspondent for FDA who will be contacted by FDA, whenever the FDA has a question about the company or its products. This individual may be someone within the company or an outside consultant. As part of our on-going commitment to better serve our U.S. Agent clients, Obelis’ US Agent, at the client’s request, will also serve as their Official Correspondent at no additional charge. While it is acceptable to identify a company employee as the Official Correspondent, for reasons of language and time zone differences, FDA prefers to communicate with someone located inside the U.S.

Preparation and/or review of Establishment Registration and Device Listing forms

All device manufacturers must register all of their establishments and devices with the FDA, before the devices can be legally marketed in the U.S. These registrations must be updated annually or whenever a significant change occurs. As an additional service to our clients, O.U.A. will prepare and/or review these forms and submit them to the FDA. Again, this service is provided at no additional charge, provided the client uses O.U.A. as their U.S. Agent.

Compliance with the U.S. Medical Device Reporting (MDR) regulations

Reporting Adverse Events: All product complaints must be assessed for MDR applicability. The reporting rules are complex with unique forms and requirements. They also change regularly. O.U.A. will assist clients in assessing complaints received from the field and ensure that the proper procedures are followed and, if necessary, that the proper forms are completed and that the FDA is properly notified. There is no additional fee to sign up for this service, and all U.S. Agent clients of O.U.A. receive a reduced rate for each complaint evaluation.

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