Premarket Submissions of Device Software Functions
In 2023, the FDA issued a new guidance: Content of Premarket Submissions for Device Software Functions. This guidance replaces their previous guidance on the subject, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices from May 2005.
Over 15 years old, the original guidance is well used and understood by industry. So the changes in this new version require significant changes in mindset about how to carry out and document software development.
This guidance document provides information regarding recommended documentation that should be included in premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions. It applies to the following types of submissions:
- Premarket Notification (510(k))
- De Novo Classification Request
- Premarket Approval Application (PMA)
- Investigational Device Exemption (IDE)
- Humanitarian Device Exemption (HDE)
- Biologics License Application (BLA)
This list has been expanded to reflect the submission types that are now available compared to those in 2005. Additional documentation may be required for post-market activities relating to software. This guidance specifically looks at premarket submissions for Device Software Functions.
The guidance also clarifies that it applies to both Software in a Medical Device (SiMD) and Software as a Medical Device (SaMD), but it does not apply to automated manufacturing and Quality System software or software that is not a device. This is a helpful delineation of scope.
How the FDA’s guidance on software documentation changes current requirements
Helen Simons has over 15 years experience in product development. She has worked on a wide range of Medical Device and IVD products, from inhalers and injection devices to phototherapy devices and ventilators. Her experience includes project managing product developments and providing quality and regulatory guidance for the US, EU and Canadian markets. Prior to StarFish, Helen worked at companies including Sagentia, Cambridge Design Partnership, and GHD. She holds a Master’s Degree in Engineering from Durham University, Durham, England. VIEW VIDEO PROFILE