Software as a Medical Device (SaMD)
The charter of the Working Group (WG) is to develop guidance that supports innovation and timely access to safe and effective Software as a Medical Device (SaMD) globally. The work is intended to identify commonalities, establish a common vocabulary and develop approaches for appropriate regulatory controls that promote prospective convergence in areas of advanced and innovative technologies in this topic area.
Note that this Working Group closed after the publication of N43 in 2017. In 2022, a new SaMD Working Group was established to provide further advice into this area. The new group's work items can be viewed here.