Premarket Submission Required before selling medical devices in the US
Substantial Equivalence Demonstrates similarity to legally marketed predicate device
Moderate Risk For devices with established benchmarks, less complex than PMA
Strategy & Planning
Identify suitable pathway based on device type
Documentation
Compile technical files and ensure compliance
FDA Communication Respond to queries and information requests
Traditional Most common type. Full submission for new devices.
Special For modifications to your own cleared device. Faster review.
Abbreviated Uses FDA guidance documents and standards. Reduced data needed.
Substantial Equivalence
Same Intended Use
Must serve the same medical purpose
Similar Technology
Comparable design, materials, and energy source
Safety & Effectiveness
No new questions raised compared to predicate
1 Submission
Digital submission with e-copy or CD
2 Review (60-90 days)
FDA evaluates substantial equivalence
3 Additional Information
AI requests or RTA notices if needed
Re-submissions must be completed within 180 days
4 Clearance
Device cleared for US market
Customized solutions based on client needs
Timely Execution Practical approach to compliance
Client-Centered Value-based, strong, and resilient team
