Thursday, December 7, 2017

FDA issues Major New Digital Guidances, Like Clinical Decision Support

On December 7, 2017, FDA issued three new guidances on digital health topics.

The guidances include two in draft, one final, and follow naturally from recent initiatives such as the "Digital Health Innovation Action Plan" *8pp) of the FDA.   Guidances today include:
  • Clinical and Patient Decision Support Software (draft)
  • Policy Changes per 21st Century Cures Act (draft)
  • Software as a Medical Device (final)
For full information and links, see the FDA's heavily hotlinked press announcement, here.  I've also put the 3 guidances and the Innovation Action Plan in one open acess cloud zip file, here.

Coverage at Fierce Healthcare, here. RAPS here.

The FDA has also announced a two day workshop (January 30-31, 2018) on its software precertification program.  Note that, Dr. Gottlieb has previously flagged the precertification program may be increasingly applicable to diagnostics at some future point.

Extra credit assignment; See Bradley Merrill Thompson's detailed multi page (web) essay on CDS history at FDA, here.  Although undated, I believe from internal references it may cover until 2012, e.g. "there will be changes in 2012."  It's a reminder that the issues in play in today's guidances have percolated many years.

See also links about the recently formed "Digital Therapeutic Alliance," here.