510(k), De Novo, PMA submission prep
Marketing application packages built around the right predicate strategy and clinical evidence framing. Whether you're filing a Traditional 510(k), De Novo, or PMA, you ship a submission CDRH can actually clear without an information request loop.
A weak predicate or evidence story costs you 3–6 months in AI/IR loops
The CDRH review clock pauses every time you receive an Additional Information request. The average 510(k) takes 3–4 review cycles, and most of those cycles are caused by predicate framing, performance testing scope, or clinical evidence questions that should have been settled before submission.
We pressure-test the submission against the actual review precedent for your product code, fix the weak spots before they become AI requests, and ship a package designed for first-cycle clearance.
A submission designed to clear, not just file
Predicate device benchmarking
Comparison against every candidate predicate (or De Novo classification rationale) with the indications-for-use, technological-characteristics, and performance comparison CDRH actually evaluates.
Performance and clinical evidence strategy
Testing plan grounded in the relevant FDA-recognized standards and recent product-code review precedent. Bridging study design where applicable.
Submission narrative and labeling
Substantial equivalence or De Novo narrative, indications for use, IFU, and labeling drafted to align with predicate scope.
FDA-formatted submission package
Full eSTAR-ready (510(k)) or PMA-modular package, with cover letters, checklists, and section-by-section assembly.
Pressure-test what you have, or have us prepare it
Pick the on-ramp that fits where you are. Both come with a fixed-fee SOW in 24 hours.
510(k) / De Novo gap analysis
We review your draft submission against current CDRH expectations and recent product-code precedent. We tell you what to fix before you file.
- Section-by-section gap analysis (10–15 pages)
- Predicate strategy review
- Top 5 AI-request risks before filing
- 1-hour readout call
Full submission package
Complete submission drafted from scratch by senior device regulatory specialists.
- Predicate device benchmarking
- Performance and clinical evidence strategy
- Submission narrative, indications, IFU, labeling
- FDA-formatted, eSTAR-ready package
Filing in the next 90 days?
Send your device, intended pathway, and current submission status. You'll get a fixed-fee proposal within one business day.