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# Guide on Off-the-Shelf Software in Devices
- URL: https://www.fdaweb.com/guide-on-off-the-shelf-software-in-devices/
- Published: 2023-08-11T12:00:00.000Z
- Updated: 2026-09-14T18:50:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5155080

FDA has released a [final guidance](https://www.fda.gov/media/71794/download?ref=fdaweb.com) entitled “Off-The-Shelf Software Use in Medical Devices” that recommends documentation sponsors should include in premarket submissions. The document describes information that would be typically generated and documented during software development, verification, and validation.

Off-the-shelf (OTS) software is commonly used in medical devices as the use of general-purpose computer hardware becomes more prevalent, the guidance says. “The use of OTS software in a medical device allows the manufacturer to concentrate on the application software needed to run device-specific functions,” it says. “However, OTS software intended for general-purpose computing may not be appropriate for a given specific use in a medical device. The medical device manufacturer using OTS software generally gives up software life cycle control, but still bears the responsibility for the continued safe and effective performance of the medical device.”

The guidance also notes that the recommended documentation is based on FDA’s experience evaluating the safety and effectiveness data for a device that uses OTS software. “However, sponsors may use alternative approaches and provide different documentation so long as their approach and documentation satisfy premarket submission requirements in applicable statutory provisions and regulations,” it says.