FDA recognizes Defect Taxonomy Consensus Standard

FDA consensus standard taxonomy

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




About the author

Brian Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®), a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.

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