Module 15 2022

19/05/2022

Statutory Standard for Safety and Effectiveness

PMA Applications – high risk devices

PMA applications must provide a “reasonable assurance of safety and effectiveness” by “weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use,” To aid in this process, PMA sponsors submit valid scientific evidence , including one or more clinical investigations where appropriate, which FDA reviews to determine whether “the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling of the device.” FDA staff review the data submitted as part of the PMA application and determine – based on a number of factors – if the data support the claims made by the sponsor concerning clinically significant results from the device, i.e., intended use and indications for use, and if the data analysis demonstrates that the probable benefits of the device outweigh its probable risks

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Statutory Standard for Safety and Effectiveness

De novo 510k 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 be sufficiently understood to explain all the risks and benefits of the device such that all risks can be appropriately mitigated through the application of general and/or special controls to provide reasonable assurance of safety and effectiveness. Further, devices classified under De Novo requests may serve as predicates for future devices which can be appropriately regulated through the 510(k) program; therefore, FDA carefully considers the benefit-risk profile of these devices in the determination that there is reasonable assurance of safety and effectiveness

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