FDA Pacemaker Pulse Generator Draft Guidance

FDA published a draft “Class II Special Controls Guidance Document: External Pacemaker Pulse Generator”. Section 6 of this document describes the information related to software validation needed in a premarekt submission. There appears to be an error with a reference to the General Principles of Software Validation guidance rather then the software submission guidance. In addition the list of items to include in this section omits the anomaly list and revision history listed in the general guidance. It is unclear if this is an oversight or intentional. The full document is at the link provided.

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