The guidance at the link provided “Quality System Informationfor Certain Premarket Application Reviews; Guidance for Industry and FDA Staff” provides FDA’s expectations for quality system information in a Premarket Approval Application (PMA). In the design validation section it requires:
“If the device is automated with computer software, you should explain how you have (or will) complete your software validation, and include any system integration testing.”
This is in addition to provision of the extensive software information suggested in FDA’s “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”. For PMAs Major Level of Concern information is usually expected.