New Draft Guidance on Content of Premarket Submissions for Software Device "Functions"


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copied from another thread:

I've only done a casual reading and my hot takes are:
  • (personal defect) I didn't really see the need for this, or at least I didn't have a strong sense of the areas or scope of issues in those areas that needed that much clarification. For now, I judge this to be a defect with me, as my casual reading was focused on the devices I work with... so issues like SaMD (or Apps) is not where I am familiar enough to make a 'hot take'.
  • Dropping to "two classifications" is fine, although I would have preferred a closer alignment with 62304.
It is possible that the FDA draft is slighter better with respect to 2-versus-3 classifications. The current 62304 schema excludes requiring detailed designs of Units for Class B, but still requires acceptance and integration of the units (again Class B). It looks like the draft sidesteps (having to explain) this.
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