In January 2019, in conjunction with its Version 1.0 of the
Working Model for the Software Precertification Program, FDA issued
a regulatory framework for conducting a
precertification pilot program, which it has currently limited to
software as a medical device (SaMD). SaMD is defined as software
intended to be used for one or more medical purposes that perform
these purposes without being part of a hardware medical device.
Specifically, FDA plans to initially implement the precertification
pilot program under its current De Novo pathway. FDA’s De
Novo pathway is a process for certain new types of low to moderate
risk medical devices to obtain marketing authorization as a class I
or class II device, rather than remaining automatically designated
as a class III device, which would typically require FDA premarket
approval.
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