Pilot for Software

FDA launched pilot for Software as a Medical Device (SaMD) Precertification program

FDA launched on August 1st a new pilot for Software as a Medical Device (SaMD) Precertification program. US software manufacturers and software manufacturers from abroad can apply for participation. FDA intends to select 9 companies to learn from their best practices of software development. Other software companies will be allowed to provide continuous input. FDA and these 9 companies (large, small, traditional, new entrant, best-in-class, low and high risk) will develop Key Performance Indicators (KPIs) to monitor whether a software manufacturer has a culture of quality and of organizational excellence.

This company culture of quality and organizational excellence needs to provide a safe patient experience; deliver the highest product quality; being clinically responsible; being cybersecurity responsible; and being proactive instead of reactive. By January 2018 FDA will report their findings. This new concept should allow faster market authorization for new innovative SaMDs through a new route of software manufacturer precertification. This precertification would result into a streamlined premarket review and a faster commercial distribution and real-world use. The software manufacturer would collect real-world data to further improve their SaMD.

For MARACA International support with your US authorization of your SaMD contact us  for a discussion and proposal.