FDA’s Office of In Vitro Diagnoitics issued a final guidance November 12, 2014 entitled “Molecular Diagnostic Instruments with Combined Functions”. It discusses the distinction between functionality being submitted to FDA for approval/clearance versus functionality that would not be regulated as a medical device. In addition to general information it contains some new specifics on dealing with software (embedded or standalone) where some of the software in the instrument is for regulated functions and some is not. It discusses the need for design controls and labeling to ensure safety and effectiveness when including combined functions.
Section V.1 recommends that regulated software be separated from other software possibly using dual boot design. Section V.3 talks about software related human factors such as greying out unapproved/uncleared functionality when in regulated mode. Section V.5 recommends that FDA be notificated of any changes to software (regulated or unregulated) that could affect the regulated functionality.