Expert Regulatory Support for Entering the U.S. Medical Device Market
The U.S. is the largest and one of the most strictly regulated medical device markets, overseen by the FDA. Manufacturers must register their establishments, list their devices, obtain FDA clearance or approval (510(k), PMA, or De Novo), follow Quality System Regulations, and use UDI labels with data submitted to the GUDID. Obelis supports manufacturers with strategy and regulatory guidance to achieve FDA approval, maintain compliance, and successfully launch devices in the U.S. market.
FAQs
Is a US FDA Agent mandatory?
Yes, non-US manufacturers must appoint a US FDA Agent.
Can the US Agent submit 510(k)?
No. The US Agent supports communication but does not replace regulatory submission responsibilities.
Does the US Agent ensure compliance?
No. Compliance remains the responsibility of the manufacturer.
Can Cert3Global act as a US FDA Agent?
Yes, we provide US FDA Agent services along with regulatory coordination support.