FDA Final Guidance Computer Software Assurance (CSA)
- Date
- February 3, 2026
- Category
US Regulations
- Description
On 24 September 2025, FDA’s CDRH and CBER issued final guidance titled “Computer Software Assurance for Production and Quality System Software”, following the draft that was issued in September 2022.
An updated version of this guidance was issued on 3 February 2026. See Computer Software Assurance for Production and Quality Management System Software.