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.