Module 15 2022

19/05/2022

Statutory Standard for Substantial Equivalence

510k Applications A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device. FDA determines whether the device is as safe and effective as the predicate device by reviewing scientific data that compares technological characteristics and performance data of the new device compared to the predicate device(s). Typically, only non-clinical data is needed. However if there are differences between the new device and the predicate device and it cannot be shown with nonclinical data that there is substantially equivalent safety and effectiveness; then a clinical evaluation could be required.

The Organisation for Professionals in Regulatory Affairs

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Valid Scientific Evidence

The Organisation for Professionals in Regulatory Affairs

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