Software Design Considerations
Overview
FDA currently has in place a 510(k) software modification guidance that provides guidelines and a flow chart on when modifications to legally marketed devices require new premarket notification (510(k)) submissions. The 510(k) software modifications guidance is specialized to tailor the general policies to the rapid software development cycle with greater reliance on risk assessment.
New FDA Draft Guidance
FDA releases new Predetermined Change Control Plans for Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff.
Benefits
Rapid deployment of changes and updates. Increased understanding of how employing different design principles influences how changes/updates are made to the software system.
Deliverables
MDIC framework outlining the benefits, shortcomings, and potential outcomes of different design architectures – from completely modular to completely connected.
Project Leadership
Matt Jacobsen, PhD
Senior Manager
Join us!
To learn more, please contact MDIC staff at DHT@mdic.org.
Medical Device Software & AI Overview
Check out the Medical Device Software & AI overview to learn more about projects, initiatives, news, upcoming events.