Software-related documentation that you provide in your premarket submission should be consistent with the intended use of the Software Device, the Level of Concern, and the type of submission. This section describes the documentation that the FDA recommends you include in your premarket submission based on the Level of Concern. However, you should follow the recommendations in device-specific guidance, if available for your device. In general, the documentation provided in your submission should:
These recommendations are keyed to the Level of Concern of your device and are predicated on your effective implementation and management of the QSR, including Design Controls.
FDA believes the recommended documents will generally be the same documents that you would normally generate during the development of a Software Device. Therefore, in a properly managed and documented medical device software development environment, the documents that you submit in response to the recommendations in this guidance may be copies of your product development documents.