Overview
Too many device companies begin development — or even manufacturing — without a clear picture of what FDA actually requires for their specific product. The result is costly surprises: wrong classification, wrong pathway, missing testing, or a submission that has to be rebuilt from scratch. Our flat-fee Medical Device Evaluation gives you the facts before you spend.
What's Included
A comprehensive written regulatory assessment delivered at a fixed, agreed-upon fee — no hourly surprises.
- Device classification under 21 CFR Parts 862–892
- Applicable product code and regulation identification
- Regulatory pathway recommendation (510(k), De Novo, PMA, Exempt)
- Predicate device identification for 510(k) candidates
- Summary of FDA-required performance testing
- Labeling requirements overview (21 CFR Part 801)
- UDI applicability assessment
- EU MDR classification and pathway overview (if requested)
- Written evaluation report — suitable for investor and board presentations
Who This Is For
The evaluation service is designed for several common situations.
- Startups with a novel device seeking regulatory clarity before fundraising
- Established manufacturers adding a new product line
- Investors or acquirers conducting regulatory due diligence
- International manufacturers exploring US market entry
- Companies that received a 510(k) rejection and need a fresh strategy
This service is also available via our dedicated platform at www.510kdevicesubmissions.com for streamlined online intake.
Why a Flat Fee?
Regulatory uncertainty is stressful enough. You shouldn't also be worried about a meter running while we work. Our flat-fee model means you know the cost upfront, and our incentive is to give you a complete, accurate answer — not to stretch the engagement.