Jun 14, 2023·FDA · Final GuidanceActiveMedium impact
FDA Device Software Functions Guidance (2023)
This guidance sets out the software documentation the FDA expects in a premarket submission, using two levels (Basic and Enhanced) based on risk. It sits alongside the cybersecurity guidance, which covers the security content.
What changed
- Replaced the older 2005 software guidance and its three Level of Concern tiers with Basic and Enhanced documentation levels.
- Software architecture and design documentation requested here overlaps with the cybersecurity architecture views.
Action for manufacturers
Keep your software architecture documents and your security architecture views consistent so reviewers see the same system in both.