Redlining Fridays - Every Friday, we share a new redlined guidance or standard
FDA updated the Clinical Decision Support Software guidance twice in January 2026?! Looks like someone spotted a few things to fix after the big January 6 release...
We ran it through our redlining tool so you don't have to read 30+ pages to find what moved.
FDA removed "time-critical decision-making" from Criteria 3 and 4. The previous version said software functions that "support time-critical decision-making and/or replace or direct the HCP's judgment" would fail Criterion 3. The Jan 29 version now only says "replace or direct the HCP's judgment." Same change in Criterion 4.
The rest is minor housekeeping: updated references, a small parenthesis cleanup, and a new guidance history table at the end (that's neat).