FDA CDRH Office of Device Evaluation issued an updated standards recognition list 4/29/03. This list contains a new software guideline recognized for laboratory instruments “Laboratory Instruments and NCCLS GP19-A2:2001 Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation, Operation, and Monitoring; Approved Guideline–Second Edition.”
Although developed for clinical laboratory instruments and data management systems the first part of this guidance provides information that could be useful for designers of user interfaces for other medical devices as well. It provides general human factors guidance as well as specific suggestions in some cases such as specific key assignments.
This guidance also provides specific suggestions and examples templates for user validation and testing. These suggestions and templates may also be useful to device manufacturer’s in their validation work even beyond clinical laboratory instruments.
This guideline can be purchased at the link provided.