FDA market access, done right.
Regulatory strategy and submission support for the US market — from device classification and FDA SaMD questions through to 510(k) clearance, De Novo authorization and the FDA interactions in between.
What we do for US-bound programmes.
Engineering and regulatory specialists working together, so the submission reflects the product you are actually building.
Regulatory strategy
Defining the US pathway, evidence expectations and sequencing against your development plan.
Device classification
Establishing device status, class and applicable regulation, including software function boundaries.
510(k) submissions
Predicate strategy and submission preparation leading to FDA clearance — not approval.
De Novo pathway
Where no suitable predicate exists, building the case for De Novo authorization and special controls.
Pre-Submission (Q-Sub) meetings
Framing the questions, preparing the briefing package and supporting the meeting with FDA.
Submission planning and preparation
Structuring the evidence set, closing gaps and assembling the submission to eSTAR expectations.
FDA interaction and correspondence
Support with Additional Information requests, deficiency responses and ongoing correspondence.
Regulatory remediation
Fixing documentation, design controls and evidence that will not survive review.
A 510(k) results in clearance; a De Novo request results in authorization. The distinction is not pedantry — it shapes your predicate strategy, your evidence burden and the claims you can make in the market. We set that expectation at the start, so the programme is planned around the right outcome.
Planning your US submission?
Tell us where the product is today and we'll map the pathway, the evidence and the FDA interactions you'll need.