Off-the-shelf software (OTS software)

Operating systems, libraries and databases are typical examples. The manufacturer still owns the risk: it has to specify, verify and monitor the OTS software and keep track of its vulnerabilities and support status.

A generally available software component used by a device manufacturer for which the manufacturer cannot claim complete software life cycle control (e.g., operating system, printer/display libraries).

FDA guidance: Content of Premarket Submissions for Device Software Functions (June 2023), Section IV, Definitions