Wednesday, October 1, 2014

FDA issues final version of long-awaited cybersecurity guidance

The long-awaited guidance will help resolve past
uncertainties about expectations of cybersecurity
in the pre-market review of medical devices.
Today, FDA issued its long-awaited cybersecurity guidance for pre-market review of medical devices.  This is a document years in the making.

A PDF of the actual guidance document appears here.

A second draft cybersecurity guidance document on post-market practices (e.g., vulnerability and incident reporting) is expected later this year.

No comments:

Post a Comment

All comments are moderated to prevent spam, so please pardon the delay while our anti-spam team looks at incoming messages.