Traditional, Special & Abbreviated 510(k) — eSTAR-Ready, Defensible, and Built to Move Fast
We help Class II device teams select the right 510(k) type, build a defendable predicate & substantial equivalence story, and develop a right-sized clinical & performance testing strategy—then assemble the full dossier in eSTAR with tight consistency and reviewer-friendly clarity.
510(k) Submission Types & Preparedness
Choose the route that is fastest and defensible for your device, claims, and evidence plan.
Traditional 510(k)
Default for most Class II devices
- Full SE narrative + comparisons
- Broad performance evidence
- Complex tech/indications
Special 510(k)
Design-control based mods
- Eligibility rationale
- V&V change traceability
- Package built for speed
QMSR Gap Audit
New 2026 FDA Standards
- ISO 13485:2016 Alignment
- Design Control Review
- Submission Readiness Report
eSTAR Rescue
Submission recovery
- 48-hr eSTAR Audit
- RTA / AI Response support
- Dossier remediation
Typical Pricing Bands
Traditional: $12,500–$45,000+
QMSR Gap Audit: $5,000–$7,500
Special / Abbreviated: $7,500–$35,000
eSTAR Rescue: $3,500–$10,000
The "Submission-Ready" Bundle
FDA’s new Quality Management System Regulation (QMSR) is now in effect. We recommend a QMSR Gap Audit before filing a 510(k) to ensure your Design History File (DHF) meets the new unified standards.
Core Capabilities (Across All 510(k) Types)
These are the building blocks that make a 510(k) defensible: strong predicate logic, clear substantial equivalence, the right evidence plan, and an eSTAR package that is easy to review.
Predicate & Substantial Equivalence
A story the reviewer can follow
- Predicate shortlist + rationale (product code/technology/indications)
- Comparison tables + differences narrative
- Evidence mapping for each material delta
eSTAR Preparation
Complete, consistent, submission-ready
- Section mapping + exhibit structure and naming
- Cross-document consistency checks
- Final QA pass to reduce avoidable RTA issues
Clinical & Performance Testing Strategy
Right-sized evidence (no surprises)
- Standards selection + test plan roadmap (bench/EMC/biocomp/software/cyber)
- Clinical necessity screening + endpoint framing (if needed)
- Traceability: requirements → risks → verification/validation → labeling
How We Run 510(k) Engagements
A simple, repeatable method that keeps documents consistent and timelines predictable.
510(k) Type + Scope
Confirm Traditional/Special/Abbreviated fit, lock intended use/indications, and define submission boundaries.
Evidence Strategy
Standards + testing roadmap (and clinical strategy if needed), mapped to risks and performance claims.
Predicate + SE + Draft
Draft core sections, build comparison tables, and ensure a coherent substantial equivalence narrative.
eSTAR + QA
Assemble in eSTAR, run final QA for completeness/consistency, and prep for RTA/AI response readiness.
FAQs
What is a QMSR Gap Audit?
As of February 2, 2026, the FDA has transitioned from the old QSR to the new Quality Management System Regulation (QMSR), which aligns with ISO 13485:2016. A gap audit identifies where your current design controls and QMS documentation fail to meet these new unified standards before they are scrutinized during a 510(k) review.
What is an eSTAR Rescue?
If you received an RTA (Refuse to Accept) or an AI (Additional Information) request, your 180-day clock is ticking. We perform a 48-hour audit of your current eSTAR file to identify gaps and draft the technical responses needed to get the review back on track.
How do we know if Special or Abbreviated will hold?
We screen eligibility/fit early: change type (Special), and guidance/recognized standards applicability (Abbreviated). If it’s borderline, we’ll recommend the safest fastest route and structure artifacts so a pivot is low-rework.
Do you handle eSTAR assembly even if we write the sections?
Yes. We can own the full build, co-author key sections, or run packaging/QA and consistency checks as a “submission quality layer.”
Ready to confirm your best 510(k) route?
Start with a quick fit check and we’ll map your device to the fastest defensible 510(k) type, evidence plan, and eSTAR build approach.
Prefer to start async?
Submit your device details and we’ll respond with a scoped plan and pricing band based on complexity, software/cyber scope, and testing requirements.