Consultation open

Medical Device Software: Considerations for Device and Risk Characterization

Start date Friday, 2 February 2024

Closing date Thursday, 2 May 2024

A Proposed Document by the International Medical Device Regulators Forum (IMDRF), Software as a Medical Device Working Group, is provided below for public comment.

Thank you for your contribution in reviewing and providing feedback for this document.

Consultation documents

Medical Device Software: Considerations for Device and Risk Characterization

• PDF (654.71 kb)
• DOCX (367.4 kb)

Please use the comments template to provide comments on the Proposed Document and send comments to email: IMDRFSaMDWG@fda.hhs.gov with the subject line ”Public Consultation on Medical Device Software: Considerations for Device and Risk Characterization”

Comments – Medical Device Software: Considerations for Device and Risk Characterization

• DOC (123.5 kb)