Sep 15, 2022

The US Food and Drug Administration has published new guidance recommending appropriate risk-based computer software assurance processes related to medical device production and quality systems in order to raise device manufacturing quality levels and improve patient safety.

The draft guidance  recommends a risk-based computer software assurance framework for computers and automated data processing systems used by medical device manufacturers for production and/or quality system purposes. The guidance also identifies tools and methods applicable to support assurance activities. Once finalized, these recommendations will supplement FDA’s guidance on validation for software as a medical device (SaMD) and software in a medical device (SiMD).

FDA’s computer software assurance risk framework

According to the guidance, computer software assurance frameworks should enable device manufacturers to both show that their software is suitable for its intended use, and that software used for production or quality management stays in a validated state (or state of control) throughout its life cycle.

FDA recommends the following components for a viable risk-based computer software assurance framework:

  • Identifying the intended use of software as either part of production or of a quality system
  • Determining appropriate risk-based approaches to be able to identify foreseeable software failures; determine whether those failures entail high process risks; and then establishing assurance processes to manage those risks
  • Determining appropriate assurance activities such as unscripted and/or scripted testing adequate to manage and/or mitigate foreseeable device or process risks
  • Establishing appropriate records for capturing objective evidence showing that companies’ software features and functions perform as intended; records should identify assurance testing methods, any issues found, date of testing and related details

“FDA believes that these recommendations will help foster the adoption and use of innovative technologies that promote patient access to high-quality medical devices and help manufacturers to keep pace with the dynamic, rapidly changing technology landscape, while promoting compliance with laws and regulations implemented by FDA,” the agency states in the guidance.

FDA will accept comments from stakeholders through November 14, 2022 on the draft guidance.

Additional US FDA medical device regulatory resources from Emergo by UL:

  • Medical software validation consulting
  • US FDA 510(k) consulting for medical devices and IVDs
  • FDA QSR (21 CFR Part 820) quality management system support


  • Stewart Eisenhart