Ranking the Importance of SaMD — Software as a Medical Device (UPDATE)

In the May 10th Pre-Cert webinar the FDA addressed an interesting risk matrix that was previously seen in the Software as a Medical Device (SaMD) guidance document, which we discussed here. While a risk matrix involving severity and probability is familiar to many, the SaMD matrix is different in that it addresses the significance of the state of health of the subject of the software and the importance of the information that the  software would provide. There are three levels for health: critical, serious, non-serious. There are also three levels for significance given as Treat or Diagnose, Drive Clinical Management, and Inform Clinical Management. Software as a Medical Device risk matrix. When arranged in a 3x3 matrix the 9 intersections are divided into four categories that then define the appropriate level of regulation. Category IV is the one in which the software has the greatest importance and it occurs only for situations in which the health condition is critical and the software is intended to be used (or perhaps will be used regardless of intent) to take an immediate or near term action. Included here is the idea that the information provided will in fact be relied on, and that the time scale does not allow for significant second guessing. This situation would be contrary to any sort of "do not rely on" disclaimer. The lowest category (I) occurs for three situations, Non-serious/Drive or Inform; and Serious/Inform. Drive occurs when the information provided will ...
Source: Medical Connectivity Consulting - Category: Information Technology Authors: Tags: Healthcare IT Standards & Regulatory Source Type: blogs