Module 15 Presentations

15/04/2024

Statutory Standard for Safety and Effectiveness

Clinical Study= Probable

De Novo /510(k) Applications

These devices are low to moderate risk devices , they may not need to confer a substantial benefit to patients in order to have a favorable benefit-risk profile

Devices granted marketing authority under De Novo requests should • Understood to explain all the risks and benefits of the device • All risks can be appropriately controlled through the application of Special Controls • Provide reasonable assurance of safety and effectiveness for the patient Devices classified under De Novo requests may serve as predicates for future devices which can be appropriately regulated through the 510(k) program

FDA carefully considers the benefit-risk profile of these devices in the determination that there is reasonable assurance of safety and effectiveness

The Organisation for Professionals in Regulatory Affairs

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Statutory Standard for Substantial Equivalence

Clinical Study= Not Likely

510(k) Applications

A 510(k) is a premarket submission made demonstrating 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 – bench performance testing • If there are differences between the new device and the predicate device = clinical data • Clinical data from OUS can be leveraged … more on this later

The Organisation for Professionals in Regulatory Affairs

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