FDA Calls for Mock SaMD Applications as Part of Test Plan

May 22, 2019

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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