Understanding your route to market in the United States
For devices substantially equivalent to predicate devices already on the market. Most efficient pathway for many medical devices.
Required for high-risk devices. Involves comprehensive clinical data review and FDA approval before commercialization.
For novel devices without predicate. Establishes new regulatory classification and may serve as predicate for future 510(k)s.
Identify an appropriate predicate device already cleared by FDA that is substantially equivalent to your device.
Demonstrate that your device is substantially equivalent in intended use, technology, and performance to the predicate.
Compile comprehensive documentation including device description, performance data, and comparative analysis.
FDA reviews submission (typically 30-90 days). Upon clearance, device can be marketed in the United States.
Many medical devices require clinical data to support 510(k) or PMA submissions. ECLEVAR MEDTECH specializes in designing and conducting FDA-compliant clinical investigations.
Key differences in regulatory approaches
Predicate device selection, substantial equivalence assessment, and submission preparation.
FDA-compliant clinical trial design and execution to support your submission.
Comprehensive device performance and safety testing to demonstrate equivalence.
Expert guidance on FDA requirements and post-market compliance obligations.
Let ECLEVAR MEDTECH guide you through FDA regulations and accelerate your path to market clearance.
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