For the latest information on FDA guidance regarding software used in medical devices, you can visit the FDA’s official website. Simply search for “software guidance documents” to find relevant guidelines and resources directly from the FDA.
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance
Disclaimer:
The information provided on this page is for convenience only. We encourage you to consult the FDA’s official website for the most accurate and up-to-date guidance. Sequenex is not affiliated with, endorsed, or approved by the FDA. Any guidance documents or regulatory advice from the FDA should be reviewed in their original context on the FDA’s website.