The Latest FDA Move To Limit Digital Health Software Regs

Law360, New York (December 21, 2017, 2:52 PM EST) -- On Dec. 8, 2017, the U.S. Food and Drug Administration issued two draft guidance documents that describe types of software functions that the FDA will not regulate, including the FDA’s long-awaited policy on clinical decision support software. The FDA published these documents in response to the 21st Century Cures Act, in which Congress removed certain low-risk digital health software from the FDA’s jurisdiction. In addition, as part of its broader Digital Health Innovation Action Plan, the FDA announced that it was adopting as final guidance a document developed by the International Medical Device Regulators Forum (IMDRF) on clinical evaluation of software...

Stay ahead of the curve

In the legal profession, information is the key to success. You have to know what’s happening with clients, competitors, practice areas, and industries. Law360 provides the intelligence you need to remain an expert and beat the competition.


  • Access to case data within articles (numbers, filings, courts, nature of suit, and more.)
  • Access to attached documents such as briefs, petitions, complaints, decisions, motions, etc.
  • Create custom alerts for specific article and case topics and so much more!

TRY LAW360 FREE FOR SEVEN DAYS