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level of concern description #7

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bewest opened this issue Mar 3, 2015 · 0 comments

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bewest commented Mar 3, 2015

Formal document to agree on de novo, basic risks and hazards, and regulatory pathway with FDA.
See #2 for more info.

Can be short, few pages, needs:

background of apps/software
agreement on basic risks
agreement on which regulations to satisfy/how
- de novo with special controls
- develop plan/roadmap to assemble review supporting materials towards approval, with joint plan on maintaining compliance and record keeping

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