FDA Releases Final Guidance on Pre-Market Submissions for Med Device Software Functions

The U.S. Food and Drug Administration (FDA) has published a final version of its Guidance on the recommended documentation on software functions in medical devices to be included in premarket submissions for FDA review.

Published in mid-June, the Guidance, “Content of Premarket Submissions for Device Software Functions,” is intended to cover a variety of software-driven functions available in today’s advanced medical devices, including firmware, software accessories, and software-only functions, such as functions intended to be operated on commercial OTS computing platforms. The Guidance does not apply to automated manufacturing or quality system software.

According to the Guidance, specific areas of software functionality that should be documented in premarket submissions include:

  • Software description
  • Risk management file
  • Software requirement specifications
  • System and software architecture design
  • Software design specifications
  • Software development, configuration management, and maintenance practices
  • Software testing as part of verification and validation
  • Software version history
  • Unresolved software anomalies

The updated Final Guidance supersedes the original version of the Guidance issued in May 2005.


As a reminder, Guidance documents issued by the FDA are intended only to represent the current thinking of the agency and are not binding on either the FDA or the public.

Read the FDA’s Final Guidance on software functions in medical devices.

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