Off-the-shelf (OTS) Software is commonly being considered for incorporation into medical devices as the use of general-purpose computer hardware becomes more prevalent. The use of OTS Software in a medical device allows the manufacturer to concentrate on the application software needed to run device-specific functions. However, OTS Software intended for general-purpose computing may not be appropriate for a given specific use in a medical device. The medical device manufacturer using OTS Software generally gives up software life cycle control, but still bears the responsibility for the continued safe and effective performance of the medical device.

This guidance document was developed to address the many questions asked by medical device manufacturers regarding what they need to provide in a premarket submission to the FDA when they use OTS Software. The specific response to these questions depends on the medical device in question and the impact on patient, operator, or bystander safety if the OTS Software fails. Thus, the answer to the question, "What do I need to document?" may differ and is based on the risk analysis that is an integral part of designing a medical device. The detail of documentation to be provided to FDA and the level of life cycle control necessary for the medical device manufacturer increase as severity of the hazards to patients, operators, or bystanders from OTS Software failure increases.

This document lays out in broad terms how the medical device manufacturer can consider what is necessary to document for submission to the Agency. A basic set of need-to-document items is recommended for all OTS Software, and a detailed discussion is provided on additional (special) needs and responsibilities of the manufacturer when the severity of the hazards from OTS Software failure become more significant.

For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices."