Just in: the U.S. Food and Drug Administration (FDA) has issued the final guidance on the Content of Premarket Submissions for Device Software Functions. This significant development provides crucial information for sponsors submitting pre-market submissions to ensure the safety and effectiveness evaluation of device software functions by the FDA.
This final guidance replaces the previous 2005 guidance and reflects the FDA's updated thinking and risk-based approach to documentation requirements for the review of device software functions in premarket submissions.
Key points about the final guidance
• Fulfilling an FDA commitment in MDUFA V, this guidance aims to provide clarity, simplicity, and alignment with current best practices and recognized voluntary consensus standards.
• Taking a simplified risk-based approach, the guidance introduces Documentation Levels (Basic or Enhanced) to determine the minimum information needed to support a premarket submission containing device software functions.
• Good news for sponsors! Until August 13, 2023, the FDA's Center for Devices and Radiological Health (CDRH) does not typically require the newly recommended information outlined in the guidance. However, any submitted information will still be reviewed if provided.
Stay updated and ensure compliance with the latest FDA guidelines by reading the full guidance on the FDA's website.