Technology innovation has undergone rapid transformation since the Food and Drug Administration first developed its “Guidance for the Content of Premarket Submissions of Software Contained in Medical Devices” in 2005. Over the past 17 years, significant advancements have disrupted the market, including the advent of the smartphone, watches that monitor your sleep and snoring habits, and smartphone-connected pacemaker devices, just to name a few.
The medical device industry has also undergone a sizable transformation, which is why the FDA recently released the “Premarket Submissions for Device Software Functions” draft guidance to keep up with the changes. Please note that while this guidance is valuable to medical device developers to get a sense of what’s to come, it is not currently being enforced.
In this eBook, we’ll cover a summary of the draft guidance, and:
- The difference between the new and old guidance
- Documentation levels: Basic vs. Enhanced
- Software documentation elements