What is fda 510 k

PMA approval typically requires a facility inspection to confirm compliance to 21 CFR prior to approval. The de novo pathway for device marketing rights was added to address novel devices of low to moderate risk that do not have a valid predicate device.

Upon successful review of a de novo submission, FDA creates a classification for the device, a regulation if necessary, and identifies any special controls required for future premarket submissions of substantially equivalent devices. Devices that are classified through the de novo process may be marketed and used as predicates for future k submissions.

Pre-subs are used for various reasons including meeting requests, to study risk determination, for submission issues, and for FDA feedback to specific questions related to a pending submission or protocol. For most Academic and Educational uses no royalties will be charged although you are required to obtain a license and comply with the license terms and conditions. For information on how to request permission to translate our work and for any other rights related query please click here.

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What is an eBook? Why is an eBook better than a PDF? Please note that FDA does not typically perform k pre-clearance facility inspections. The submitter may market the device immediately after k clearance is granted. The manufacturer should be prepared for an FDA quality system 21 CFR inspection at any time after k clearance. A k requires demonstration of substantial equivalence to another legally U.

Substantial equivalence means that the new device is as safe and effective as the predicate. A claim of substantial equivalence does not mean the new and predicate devices needs to be identical.

FDA first establishes that the new and predicate devices have the same intended use and any differences in technological characteristics do not raise different questions of safety and effectiveness.

FDA then determines whether the device is as safe and effective as the predicate device by reviewing the scientific methods used to evaluate differences in technological characteristics and performance data. Submit the required documentation to the FDA to get approval for the device. Are you interested in learning more about our Quality Management Software? View Related Pages.

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