Draft Guidance on the Device Software is expected by FDA

This week, the US Food and Drug Administration (FDA) released draught advice for its Content of Premarket Submissions for Device Software Functions. The guidance, published online on November 4, outlined the documentation that should be included in premarket submissions so that the FDA can assess the safety and effectiveness of device software features.

The FDA draught recommendations focus on device software functionalities – specifically, software in a medical device (SiMD) and software as a medical device (SaMD) – and define data created and documented during software design, development, verification, and validation. The guidance would replace the more than 16-year-old Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices once finalized after a public comment period.

It is a significant revision of that text, which was first published in May 2005, when the current technological landscape was unimaginable. The agency’s regulatory approach has developed dramatically since then, just as the maturity and capabilities of medical devices have. According to Bakul Patel, director of the Digital Health Center of Excellence, the new draught describes the information that the FDA considers vital during its evaluation of the safety and effectiveness of device software with one or more device functions, including both software in a medical device and software as a medical device.

Patel mentioned complete product life cycle approach to AI-powered software-as-a-medical-devices in a speech a year ago about the promise and possibilities for medical technology, significantly as artificial intelligence and machine learning grow. The FDA acknowledges that the landscape is changing and is working to provide the most up-to-date information on regulatory considerations for device software functionalities consistent with current standards and best practices.