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# Device Software Submission Guidance
- URL: https://www.fdaweb.com/device-software-submission-guidance/
- Published: 2023-06-13T12:00:00.000Z
- Updated: 2026-09-14T18:38:57.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154674

FDA has published a guidance, *Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices*, to give the industry information about the documentation the agency recommends be included in premarket submissions for software devices, including standalone software applications and hardware-based devices that incorporate software. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions?utm%5Fmedium=email&utm%5Fsource=govdelivery) is a result of ongoing efforts to state agency recommendations more clearly and ensure they remain current as technology advances, FDA says. It combines two previous guidances into one.

The guidance contains an Introduction, Least Burdensome Approach, Scope, Relationship to Other Documents, Terminology, Level of Concern, Determining Level of Concern, Software-related Documentation, the Special 510(k) Program, the Abbreviated 510(k) Program, Additional Topics, and References.