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510(k) Clearance Process for Medical Devices

As indicated in OnemataDC’s U.S. Medical Device Regulations article, the 510(k)-review pathway can be used to obtain FDA clearance for a moderate to low-risk device when a predicate or similar established device is available.  Per the FDA’s guidance found in The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], one path forward in obtaining FDA clearance of low risk Class I and Class II medical devices involves “a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market.”


Finding a proper predicate device is paramount to obtaining FDA clearance under the 510(k) process and proving that your medical device has similar questions of safety and efficacy can be challenging.  OnemataDC’s team is built to research and identify a solid predicate device while putting your medical device and associated data through their paces to help ensure they meet the FDA’s substantially equivalent test prior to the 510(k) submission.


With a sound and innovative regulatory strategy, the 510(k) can be the quickest and most cost-effective path to obtain commercial authorization.  An experienced guide can help identify and correct pitfalls before it’s too late.  OnemataDC’s team is experienced with 510(k) submissions and expert at right-sizing and remediating our clients’ quality management systems.


Let OnemataDC help lead the way – drop us note today!

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U.S. Medical Device Regulations

The U.S. Food and Drug Administration (FDA) is in part responsible for ensuring the public has access to safe and effective medical products

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