International Sponsor Program
U.S. Agent, 510(k)/De Novo, and digital health submission support for UK device manufacturers entering the U.S. market.
The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices in the UK. UK manufacturers typically hold UKCA marking, and often CE marking as well for continued EU market access, as their home-market regulatory baseline — the U.S. FDA pathway is a separate, additional process built on top of that baseline, not a continuation of it.
Because UK manufacturers typically already hold ISO 13485 certification to support UKCA/CE marking, the most common quality-system task for a UK company entering the U.S. market isn't building a new quality system — it's mapping an existing, certified ISO 13485 system against FDA's QMSR (21 CFR Part 820) requirements and closing the specific gaps where the two frameworks diverge.
UK manufacturers pursue the same FDA pathway analysis as any other market: a 510(k) where a suitable predicate exists, or a De Novo classification request where the device has no predicate but presents low-to-moderate risk. Predicate research often benefits from the UK manufacturer's existing UKCA/CE technical file, which already contains much of the device description and risk analysis an FDA submission needs, adapted to FDA's format and evidentiary expectations.
UK digital health and AI/ML device developers bring ADB submissions needing SaMD classification, software documentation level determination, and — where the algorithm is expected to evolve post-market — Predetermined Change Control Plan development, following the same FDA framework as any other SaMD submission regardless of origin.
UK time runs roughly 5 hours ahead of U.S. Eastern Time, which puts a UK team's afternoon into a U.S. Eastern morning — a comfortable overlap window for scheduled calls, with the client portal carrying written updates and FDA correspondence the rest of the day.
Common Questions
UKCA/CE technical documentation can be adapted to support an FDA submission and may reduce the drafting effort, but FDA conducts its own independent review under its own regulations — UKCA or CE marking is not accepted as a substitute for FDA clearance or approval.
ISO 13485 certification is a strong starting point since FDA's QMSR incorporates ISO 13485:2016 by reference, but the two frameworks aren't identical — a gap assessment against the specific QMSR requirements not already covered by ISO 13485 is still the right first step.
The pathway depends on whether a predicate device exists: a 510(k) if one does, or a De Novo classification request if the device is novel but presents low-to-moderate risk. The SaMD risk framework and software documentation level determination apply the same way regardless of the device's country of origin.
Yes — any foreign establishment required to register with FDA under 21 CFR Part 807 must designate a U.S. Agent residing or maintaining a place of business in the United States, and this applies to UK manufacturers the same as manufacturers from any other country.
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30 minutes to assess your U.S. Agent, submission, or IDE sponsor needs.