US FDA Consulting
US FDA Consulting at Materials Metric provides end-to-end regulatory guidance to help companies efficiently navigate complex FDA pathways, including 510(k), De Novo, PMA, IDE, and Q-Submission processes. We work closely with clients to align scientific evidence, testing strategies, and regulatory expectations early in development, reducing uncertainty and costly delays. By translating FDA requirements into clear, actionable plans, Materials Metric supports defensible submissions, effective agency communication, and smoother progression from development through clearance or approval.
Uses
• Determine correct regulatory pathway
• Prepare Q-Sub questions and meeting content
• Develop FDA-ready testing strategies
• Support 510(k), De Novo, PMA, and IDE submissions
• Resolve regulatory questions and data gaps
Applications
• Class I–III medical devices
• Biomaterials & coatings
• Diagnostic platforms
• Implantable and combination products
Consulting Process
1. Regulatory Pathway Definition
- 510(k) predicate identification
- PMA/De Novo justification
2. Testing Strategy Development
- Performance testing
- Biocompatibility & chemical safety
- Sterilization & shelf-life requirements
3. Submission Support
- Technical documentation
- Rationales & scientific argumentation
- FDA interaction support
Why Choose Materials Metric
Materials Metric brings deep scientific and regulatory expertise essential for successful FDA submissions.
We offer:
• ISO 9001:2015 aligned documentation
• Cross-disciplinary scientific knowledge
• FDA-recognized testing strategies
• Strong scientific justification for claims
• Efficient, structured submission guidance
We help ensure your submission is complete, defensible, and aligned with FDA expectations.
Related services