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Medical Devices / Regulatory Affairs

FDA Testing Supports a Streamlined Review of SaMD

Aug. 12, 2019
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The FDA announced that it has completed retrospective testing and the results indicate a regulatory decision can be made using the information acquired from a streamlined review of software as a medical device (SaMD).

This conclusion comes as part of the FDA’s 2019 mid-year update of its software pre-certification program.

The pre-cert program entered its test phase earlier this year, with the goal of confirming that the streamlined review pathway created for SaMD products provides the same assurance of safety and effectiveness for SaMD as the FDA’s traditional review pathway for medical devices.

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