Traditional & Special 510(k) Builds — Clean, Defensible, Complete
We help device companies plan, assemble, and submit 510(k)s with a strategy that holds up under review: predicate logic, indications, risk management, testing plans, labeling/IFU, and eSTAR-ready dossiers.
Why 510(k)s Fail (and How We Prevent It)
Most 510(k) delays are preventable: unclear indications, weak predicate rationale, missing standards/testing justification, inconsistent labeling, or risk files that don’t match the submission narrative. We build the story and the artifacts together, so reviewers see a coherent device with justified performance and controls.
- Predicate logic: substantial equivalence starts with accurate comparisons and scoped indications.
- Testing readiness: you need the right standards, test plans, and traceability to requirements.
- Labeling alignment: IFU, contraindications, warnings, and claims must match what you tested and what you submit.
- Risk & software documentation: IEC/ISO artifacts must connect cleanly to hazards, mitigations, and verification.
510(k) Programs
Clear programs, clean deliverables, pricing bands based on scope and device complexity.
510(k) Strategy Sprint (Predicate + Plan)
Typical range: $2,500–$7,500
For teams that need the right pathway, predicate, and evidence plan before spending money on testing.
- Device + claims triage: indications, intended use, marketing boundaries
- Predicate shortlist + substantial equivalence framing
- Standards/testing roadmap (bench, EMC, biocomp, software/cyber as applicable)
Special 510(k) Package
Typical range: $7,500–$18,000
For eligible modifications where design controls and verification support a streamlined submission.
- Eligibility assessment + Special 510(k) rationale
- Submission drafting + eSTAR assembly support
- Traceability: requirements → verification/validation → labeling
Traditional 510(k) Full Build
Typical range: $15,000–$45,000+
For complete, submission-ready 510(k)s—assembled, validated, and consistent across the entire dossier.
- Full narrative drafting: device description, substantial equivalence, performance, labeling
- Testing coordination support (plans, vendor inputs, report review, gap closure)
- eSTAR-ready compilation + quality checks for consistency and completeness
RTA Fixes & Deficiency Responses
Typical range: $1,500–$12,000
For teams that got an RTA hold or an AI/Deficiency letter and need a clean, fast response package.
- Gap mapping: each FDA item → location, owner, and required evidence
- Response drafting + updated documents (labeling, comparisons, summaries)
- Submission re-assembly checks to prevent “new” inconsistencies
Who We Help
First-Time 510(k) Sponsors
Startups and first-time manufacturers building a coherent submission with the right scope and testing plan.
Established Manufacturers
Teams with design controls who need Special 510(k) eligibility, clean documentation, and an efficient build.
Software & Connected Devices
Products needing software documentation, cybersecurity, EMC, wireless, and clear essential performance narratives.
Testing-Heavy Devices
Devices requiring biocompatibility, sterilization, shelf life, packaging, or electrical safety/EMC documentation.
Stalled Submissions
Teams facing RTA holds or deficiency letters who need structured responses that close issues decisively.
Private Label / OEM Structures
Companies navigating who “owns” the clearance, how to reference predicates, and what requires a new submission.
How We Run 510(k) Engagements
Simple phases, tight documentation control, and submission-ready deliverables.
Indications & Predicate
Lock indications/intended use, predicate logic, and the comparison framework so the submission has a stable core.
Standards & Test Plans
Define standards, testing strategy, and documentation requirements—then map vendors and timelines.
Draft + Assemble in eSTAR
Draft the dossier, validate consistency across sections, and build the eSTAR package to reduce review friction.
RTA/AI Response Support
When FDA asks questions, we respond with evidence, clarity, and document control—without creating new issues.
510(k) FAQs
Should I file a Traditional or Special 510(k)?
It depends on whether the change is eligible for Special 510(k) and whether your design controls and verification are complete. We can quickly assess eligibility and recommend the fastest defensible route.
Can I “use another company’s 510(k)” as my clearance?
You can reference publicly available information, but you generally cannot claim someone else’s clearance as yours. OEM/private label scenarios are nuanced—structure and manufacturer identity matter.
What do you need from me to start?
Device description, intended use/indications draft, current labeling/IFU, risk artifacts (if any), testing status, and any prior FDA correspondence. If you don’t have these yet, we start with a strategy sprint.
Are these pricing ranges fixed?
No—these are typical bands. After a short triage call we can provide a fixed or milestone quote based on device class, software/cyber scope, testing breadth, and current documentation maturity.
Talk Through Your 510(k)
Share your device type, intended use, and where you are with testing and documentation. We’ll outline a sequenced plan (scope → evidence → build → submit) with clear deliverables and a quote that matches your timeline.
Based in Charleston, SC • Supporting device teams worldwide
Prefer direct email? info@verusfda.com