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FDA 510(k),
Clearance to Market in the US
We help medical device manufacturers navigate FDA premarket notification and achieve clearance to legally market their devices in the United States.
- A division of Liberty Management Group Ltd — established 2009
- Aurora, IL · Greater Chicago
- Submission-ready documentation
- On-time delivery
Substantial Equivalence, Properly Evidenced
What a 510(k) has to show
A premarket notification demonstrates that your device is substantially equivalent to a legally marketed predicate device. The strength of the submission rests on predicate selection and on the evidence supporting that equivalence.
- Device classification and regulatory pathway determination
- Predicate research and the substantial equivalence rationale
- Indications for use and device description
- Performance testing plan and review of existing evidence
- A complete submission package prepared in the FDA eSTAR format
Through to clearance
Submission is the midpoint, not the end. We manage the correspondence that follows, including Additional Information requests, so review cycles do not stall over avoidable gaps.
- Pre-Submission (Q-Sub) meeting requests where the pathway is unclear
- Acceptance review and Refuse to Accept checklist preparation
- Responses to FDA Additional Information requests
- Labelling reviewed against the claimed indications for use
- Establishment registration and device listing guidance
Before you submit
The most expensive problems in a 510(k) are decided early — the wrong predicate, or testing that does not support the claimed indications. A short review of your device and its intended use at the outset usually saves a full review cycle later.
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