FDA Clearance + Compliance Foundation for International Manufacturers
A structured, phased program to achieve U.S. FDA market access—built for portfolio execution, predictable budgets, and inspection-ready operations under QMSR.
Built for EU MDR / ISO 13485 manufacturers, orthopedic implants, surgical devices, and scalable U.S. entry programs.
Who this program is for
Built for teams seeking U.S. market access with a durable compliance backbone—not one-off “advice.”
International manufacturers
EU, UK, and global manufacturers entering the U.S. market for the first time or expanding product lines.
- EU MDR / ISO 13485 documentation leverage
- U.S. Agent + registration/listing readiness
- Time-zone friendly coordination
Implant & surgical portfolios
Orthopedic, spine, trauma, extremity, and procedure-driven device families that benefit from sequencing.
- Multi-line predicate architecture
- Shared testing strategy
- Submission roadmap (3–5+ filings)
Funded device companies
Teams who need execution: drafting, packaging, and review-cycle support through clearance.
- Operational cadence + ownership
- eSTAR-ready compilation
- AI response management
Not sure if you fit?
We’ll tell you quickly if 510(k) is appropriate, how many filings your portfolio likely needs, and the fastest credible plan.
The 4-pillar U.S. entry model
A coordinated program reduces total regulatory spend and accelerates market access—especially for multi-line portfolios.
1) Classification & product code mapping
We map each device family to FDA expectations so pathway, data needs, and reviewer context are clear.
- Regulation + product code mapping
- Device family segmentation + scope boundaries
- Early risk identification (RTA / data gaps)
2) Predicate architecture & SE strategy
We design predicate selection and substantial equivalence arguments for reviewer clarity and portfolio leverage.
- Predicate shortlist + rationale
- SE comparison matrix + tech characteristics narrative
- Multi-predicate strategy when needed
3) Testing reuse & evidence strategy
We build a master evidence plan to reduce redundant testing across portfolio submissions.
- Standards mapping (ASTM / ISO / FDA-recognized)
- Gap analysis: what you have vs what FDA expects
- Protocol recommendations + lab coordination support
4) QMSR + inspection-ready operations
We align submission-facing documentation and operating processes so you’re ready post-clearance.
- QMSR gap analysis + prioritized remediation
- Medical Device File (MDF) documentation alignment
- UDI / MDR reporting / labeling readiness
Detailed services included
Scope is sequenced so each phase produces tangible outputs and decision points—protecting timelines and budgets.
Intended use framing, device family scope definition, classification mapping, and pathway alignment.
Predicate selection, SE comparison matrix, tech narrative, and argument architecture.
Standards mapping, evidence review, gaps, and recommended testing protocols.
End-to-end drafting + assembly aligned to eSTAR and RTA expectations.
510(k) execution to completion
- Device description + intended use / indications alignment
- Performance testing summary and rationale
- Biocompatibility summary (from existing evidence)
- Labeling review and U.S. compliance alignment
- eSTAR formatting and submission packaging
- FDA review support + AI response drafting support
U.S. market entry infrastructure
- U.S. Agent designation support (foreign manufacturer requirement)
- Establishment Registration + Device Listing support
- Small business qualification support (if eligible)
- QMSR gap analysis + inspection readiness alignment
- Portfolio sequencing plan (for multi-line programs)
Want the fastest credible path?
We’ll review your portfolio, identify submission count drivers, and propose a phased roadmap aligned to commercial priorities and evidence readiness.
Key deliverables
Outputs you can circulate internally (leadership, QA, R&D, labs, distributors) to keep alignment tight and decisions fast.
Classification & portfolio map
A device-family segmentation and product code map used to define submission count and sequencing.
- Device family boundaries
- Product code candidates
- Submission sequencing recommendations
Predicate & SE dossier
Predicate shortlist, selection rationale, and a structured SE comparison framework designed for reviewer clarity.
- Predicate decision logic
- SE comparison matrix
- Argument architecture
Master evidence plan
A testing and documentation reuse strategy that reduces duplication and avoids late surprises.
- Standards mapping
- Evidence gaps + protocols
- Reuse opportunities across filings
Submission-ready eSTAR package
A complete, organized 510(k) package aligned to RTA expectations and reviewer consumption.
- Full 807.87 section coverage
- Clear cross-referencing
- Coherent narrative + tables
QMSR alignment pack
Targeted transition support built around your ISO 13485 system, with U.S.-specific requirements addressed.
- QMSR gap analysis
- MDF alignment approach
- UDI / MDR reporting readiness
FDA review support
Support through review, including response packaging to keep timelines moving.
- AI request triage
- Draft responses + exhibits
- Review cadence and tracking
Indicative timeline
Timelines depend on evidence readiness, but once intake is complete, this model is built to move fast.
Single device family (typical)
- Week 1: assessment, classification, predicate shortlist
- Week 2: SE matrix + evidence plan
- Weeks 3–4: drafting + assembly + internal review
- Submission: eSTAR filed upon approval
- FDA review: typically ~90 days (AI pauses apply)
Portfolio program (phased)
- Phase 0: portfolio map + sequencing
- Phase 1: establish first clearance (creates predicate leverage)
- Phase 2+: roll filings using reused evidence/templates
- Cadence: 3–5 submissions over 18–36 months (typical)
- Outcome: compounding efficiency and lower total spend
Let’s define your submission count and sequencing.
In one session, we identify likely submission families, predicate options, and an evidence plan supporting a phased clearance roadmap.
Why Verus FDA
International manufacturers need an execution partner who understands reviewer expectations and drives to completion.
Execution to completion
We own the workstream—from strategy to packaging to review support—so you don’t get stuck with half-built deliverables.
- Clear process + accountability
- Submission-ready outputs
- Review-cycle support
Portfolio-level thinking
We build predicate architecture and evidence reuse so each submission strengthens the next.
- Sequenced clearances
- Reusable templates
- Reduced duplication
QMSR + inspection readiness
Clearance is not the finish line. We embed QMSR/inspection readiness into market entry from day one.
- QMSR gap analysis
- MDF documentation alignment
- U.S.-specific obligations
Note: Third-party costs (FDA user fees, laboratory testing, registration fees) are separate from professional services and are confirmed in writing before commitment.
Frequently asked questions
Common questions from EU MDR / ISO 13485 manufacturers entering the United States market.
Do we need a U.S. distributor before filing a 510(k)?
No. A distributor is not required to file or receive a 510(k). Foreign manufacturers do need a U.S. Agent and Establishment Registration / Device Listing prior to submission acceptance and commercialization.
Can we pursue U.S. clearance while EU MDR work is ongoing?
Yes. EU MDR and FDA 510(k) are independent and often executed in parallel to accelerate time-to-market. Existing ISO 13485 documentation can provide strong leverage.
How does QMSR impact submissions and inspections?
QMSR incorporates ISO 13485:2016 by reference into 21 CFR Part 820 and changes inspection expectations. We align submission-facing documentation and quality processes so you’re prepared for U.S. obligations after clearance.
What happens if FDA issues an Additional Information (AI) request?
AI pauses the review clock until a response is submitted. We draft and package responses with supporting exhibits so review restarts quickly and the request scope stays contained.
How many 510(k)s will our portfolio require?
It depends on device family boundaries (intended use, design, materials, technology). Closely related variants may fit within one filing; we recommend a submission count after portfolio mapping.
Request a portfolio review
Send a short summary of your device families and priorities. We’ll reply quickly with next steps.
What to include
- Device family list (or product catalog)
- Intended use / indications (draft is fine)
- Materials and sterilization method (if applicable)
- Existing test evidence (mechanical, biocomp, etc.)
- Commercial priorities + target launch timing
Tip for international teams: include preferred meeting windows in CET/UTC and we’ll accommodate.
What you’ll get after the call
- Likely submission count drivers and family boundaries
- Initial predicate strategy direction
- Evidence plan outline + likely testing gaps
- Phased roadmap aligned to commercial priorities
- Fixed-scope proposal (single family or portfolio program)
This page is informational and does not constitute legal advice. Engagement begins only after a mutually executed agreement.