In an attempt to stay current with the ever-evolving device technology environment, the FDA has published draft guidance for its Content of Premarket Submissions for Device Software Functions. This new guidance was created to address myriad changes in the device software landscape, and provides a clearer picture of what documentation should be attached to premarket submissions. The FDA will subsequently be able to streamline its safety and effectiveness evaluations with the appropriate set of materials at hand.
After passing a public content period, this adjusted guidance will take the place of the FDA's relatively ancient Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Replacing that 16-year-old, catch-all guidance drafted in the mid-aughts will better represent the then-unimaginable complexity of medical device technology as well as the increased maturity associated with the agency's regulatory procedures.
The recommendations are tied specifically to device software functions, with software-as-a-medical device (SaMD) and software-in-a-medical device (SiMD) being the most prominent technologies represented. Additionally, the guidance covers data that is produced and documented during the processes of software design, development, verification, and validation.
This isn't the only effort from the agency to keep pace with emergent technologies in the sector. Last month, the FDA published a "guiding principles" list meant to support the safe and effective development of AI-centric medical devices. The desire in this instance is to set a solid baseline for what it calls Good Machine Learning Practice.