21

Jun

2011

FDA Draft Guidance Low Glucose Suspend Systems

devicecenter, fda

0

On June 21, 2011 FDA released a draft for comments of a new guidance titled: “The Content of Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications for Low Glucose Suspend (LGS) Device Systems` dated June 22, 2011. The comment period ends 90 days from issuance. The guidance mentions software in many places both referencing general software guidances and requiring specific information for these types of devices. The software in these devices is defined as Major Level of Concern by the guidance. Section G. Page 41 talks about “in-silico” testing essentially computer modeling as a reasonable non-clinical testing method. The guidance discusses information to provide in the IDE versus the PMA ubt stresses the need to provide a full unresolved anomaly list even in the IDE and explain the clinical impact or lack thereof. The guidance emphasizes provision of algorithm and system communication information and verification. The full guidance is at the link provided.

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