Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices


This document discusses the expectations of the Food and Drug Administration (FDA) as a regulator of software contained in medical systems, defining a submission as a concept similar to the safety case.

The determination of whether a system is safety-critical is based upon its impact upon patients, including indirect impact via use in the development of medical devices.

The "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" defines a "level of concern", (similar to the severity used in many other safety standards): major (death or serious injury), moderate (non-serious injury) and minor (no injury).

A decision process is based on a questionairre, focussed on medical issues (in a similar fashion to Def(Aust) 5679 "The Procurement Of Computer-based Safety Critical Systems" providing a questionnaire for defence issues) to determine the level of concern and from this the rigour with which software processes are to be applied.

The submission is required to contain details on hazard identification, risk assessment, and the software life cycle. The greater the level of concern, the greater the detail required in the submission.

It places special emphasis on clinical testing, and discusses the use of feedback in either closed loop or target control systems.

Download:

http://www.fda.gov/cdrh/ode/software.pdf from the Food and Drug Administration (FDA).