We will slowly add checklists for a few different FDA Guidance documents. Requirements in guidance documents will likely be less clearly defined than in ISO standards.
It may also be useful to extend the checklist format a bit so we can keep the documents simple. In particular, it may be nice to include lines like:
FDASG:4.2==62304:5.1.3 Optional comment goes here
to indicate that meeting this part of 62304 also meets the related guidance requirement.
We will slowly add checklists for a few different FDA Guidance documents. Requirements in guidance documents will likely be less clearly defined than in ISO standards.
It may also be useful to extend the checklist format a bit so we can keep the documents simple. In particular, it may be nice to include lines like:
to indicate that meeting this part of 62304 also meets the related guidance requirement.