What’s changed in the Draft Guidance for Content of Premarket Submissions for Device Software Functions?

FDA issues long-awaited draft software guidance in overhaul of 16-year-old policy, recommending documentation to include in premarket submissions for medical devices that use software. What’s changed in the Draft Guidance for Content of Premarket Submissions for Device Software Functions? Pooja Kartik, Triple Ring’s VP Quality & Regulatory, emphasizes the three new definitions of Device Software Function, Software as a Medical Device (SaMD), Software in a Medical Device (SiMD) and does comparisons between 2005 Guidance with 2021 Draft-Enhanced version in the recent software article she compiled. If you are interested in learning more about the major changes in the draft guidance and how this might affect your business, please click here to read the full article.