Software As A Service Fda. The international medical device regulators forum IMDRF of which the US FDA is a member describes SaMD as software that may work on general-purpose non-medical computing platforms. Risk-Based Validation with Time-Saving Templates.
The international medical device regulators forum IMDRF of which the US FDA is a member describes SaMD as software that may work on general-purpose non-medical computing platforms. Software as a Service SaaS. Clinical Evaluation Guidance for Industry and Food and Drug Administration Staff.
Clinical Evaluation guidance document Guidance.
In the Cures Changes guidance FDA proposes that software functions in the second category abovethe living well with disease categoryare not exempt from the statutory device definition because they relate to the mitigation or prevention of a disease or condition. The goal of the final Guidance is to establish a common understanding of clinical evaluation and principles for demonstrating the safety effectiveness and performance of SaMD. Software functions that are used in active patient monitoring to analyze patient-specific medical device data and therefore are the focus of the FDAs regulatory oversight including software. However FDA software validation can be a complex process.
