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510(k) Clearance Process for Medical Devices
The 510(k)-review pathway can be used to obtain FDA clearance for a moderate to low-risk device when a predicate device is established.
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De Novo Classification Request for Medical Devices
Low and moderate risk medical devices may require a De Novo Classification Request if there is no predicate or similar established device.Â
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Premarket Approval for Class III Medical Devices
High risk medical devices or Class III devices, require a successful Premarket Approval (PMA) application prior to being legally marketed to
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