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# Software Function Premarket Submission Guidance
- URL: https://www.fdaweb.com/software-function-premarket-submission-guidance/
- Published: 2021-11-03T12:00:00.000Z
- Updated: 2026-09-14T17:21:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150501

FDA has published a draft guidance, *Content of Premarket Submissions for Device Software Functions*, with information on the recommended documentation sponsors should include in premarket submissions for the agency’s evaluation of the safety and effectiveness of medical device software functions. When final, the [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/content-premarket-submissions-device-software-functions?ref=fdaweb.com) will replace a 5/11/2005 guidance and will update FDA’s thinking related to the documentation it recommends sponsors include for the review of device software functions in premarket submissions.

FDA says the recommendations in the guidance pertain to device software function, including software in a medical device and software as a medical device.

The guidance contents are Introduction, Background, Scope, Definitions, Documentation Level, Recommended Documentation, Additional Information, and two appendices.