FDA support
Strategy and preparation for manufacturers taking a device to the US: finding the right classification and pathway, building a 510(k), and aligning the quality system with the FDA's Quality Management System Regulation.
Frameworks covered
- 21 CFR Part 820 (QMSR)
- 510(k)
- ISO 13485
What we support
- Regulatory strategy
- Which pathway fits your device, what evidence it needs, and how US work fits with your Canadian and EU plans.
- Classification
- Identifying the product code and classification regulation, and whether a 510(k) is needed at all.
- 510(k) preparation
- Predicate selection, substantial equivalence arguments and assembling the submission.
- QMSR alignment
- Checking an ISO 13485 quality system against the QMSR and closing the FDA-specific gaps.
Situations we help with
- You hold a Canadian licence or a CE mark and want to know what the US adds.
- You have a candidate predicate but are not sure the comparison will hold.
- Your quality system was built for ISO 13485 and you need to know what the QMSR changes.
Our role
FDA support is consulting only. We do not act as a U.S. Agent or Official Correspondent. If your company needs one, we can tell you what the role involves so you can appoint one.
Common questions
What is the QMSR?
The Quality Management System Regulation is the FDA’s revised 21 CFR Part 820. It incorporates ISO 13485:2016 by reference and took effect on February 2, 2026, replacing the former Quality System Regulation.
Can you act as our U.S. Agent?
No. Our FDA work is consulting only.
Start with a market intelligence scan
Before a regulatory engagement, a scan built from public Health Canada, FDA and EU data shows whether comparable devices are already licensed, who holds the licences, and which route is likely. Every report cites its sources, the date the data was pulled, and the coverage limits.
Tell us about your device and the market you are aiming for.
A first conversation covers the device, its likely classification, where you are today and the date you are working to. Every enquiry goes through Crossbridge Partners, so there is one point of contact.
Discuss your regulatory pathway