FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

FDA Calls for Mock SaMD Applications as Part of Test Plan

May 23, 2019
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The FDA is asking for test cases from software developers that plan to submit De Novo requests or 510(k) submissions for software as a medical device (SaMD).

The agency wants submissions from small and large development companies, as well as non-traditional devicemakers and developers of both low- and high-risk SaMD.

The mock submission trial is part of the pre-certification pilot  program that’s helping the agency to develop a regulatory model for SaMD. The pre-cert program looks initially at the software developer rather than the product being developed.

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