On Jan 14, 2019, FDA recognized ANSI AAMI SW91:2018 Classification of defects in health software.  The FDA recognition statement for this standard does not indicate any specific use in premarket submissions or relevant FDA guidances. It simply states it supports existing policies.  This standard is lengthy and technical in terms of its approach to defect classification and focuses on technical and process root causes rather than clinical safety and effectiveness impact.  One possible use of this standard is to consider some of the types of defects including those in the Annexes when doing software risk analysis and root cause investigations.  Its possible in the future some FDA staff may familiarize themselves with this standard and ask if some of these types of defects have been considered during development, failure analysis, or in defect trending for CAPA.

This standard addresses the gap for an agreed upon or common approach for categorizing software defects to aid in analysis and recognition of trends.  Many companies have their own approach but thus far there has been no way to aggregate data across the industry for the common benefit of all.  SW91 is intended to address this gap and provide a common taxonomy.

Action you should take?  Consider how you could improve the problem resolution or defect handling process at your company using SW91 taxonomy.  Although not addressed in the standard, SoftwareCPR® often recommends identifying and trending defects that compromise risk control measures or contribute to hazards at least in latter stages of product development.

FDA Information:

Link to FDA notice:  FDA FR Recognition List Number 051

Scope/Abstract:  This standard provides a common language for the classification of defects occurring in health software.

Extent of Recognition:  Complete standard

Rationale for Recognition:  This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Relevant FDA Guidance and/or Supportive Publications:  There is no relevant guidance developed at this time.

FDA Technical Contact:  Lisa Simone, FDA/OMPT/CBER/OBRR

301-796-2591

Lisa.Simone@fda.hhs.gov