Key points:

🔹 The FDA guidance document provides recommendations on the content of premarket submissions for device software functions.

🔹 The recommendations are intended to help manufacturers demonstrate the safety and effectiveness of their software-controlled devices.

🔹 The guidance covers topics such as the software design, development, and testing process; the risk management process; and the postmarket surveillance plan.

🔹 The guidance is intended to be used in conjunction with other FDA guidance documents on software validation and risk management.

🔹 The guidance is not legally binding, but it is considered to be a good practice for manufacturers of software-controlled devices.

🔗 Original Document:  https://www.fda.gov/media/153781/download