Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

051

Date of Entry 01/14/2019

FR Recognition Number

13-105

Standard

ANSI AAMI SW91:2018
Classification of defects in health software

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.

NOTE: Conformance to this standard may not satisfy all the cybersecurity requirements outlined in Section 524B of FD&C Act or the recommendations in the (1) listed below (Relevant FDA Guidance). Manufacturers should consider the information contained within these resources in their assessment of cybersecurity for their device.

Relevant FDA Guidance and/or Supportive Publications*

1. Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions, Guidance for Industry and Food and Drug Administration Staff, issued February 2026.

2. Content of Premarket Submissions for Device Software Functions, Guidance for Industry and Food and Drug Administration Staff, issued June 2023.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contacts

Lisa Simone

FDA/OC/CDRH/OSPTI/ORR/DAHPR/

301-796-2591

Lisa.Simone@fda.hhs.gov

Binoy Mathews

FDA/OC/CDRH/OPEQ/OHTI/DHTIC/

301-796-6475

Binoy.Mathews@fda.hhs.gov

Standards Development Organizations