Dec 8, 2017


  • US FDA has issued three new guidances focused on digital health technology regulations.
  • The guidances stem from 21st Century Cures Act requirements for timelier registration processes for digital medical technologies.

US FDA digital health technology guidance documents December 2017The US Food and Drug Administration has published three guidance documents related to the agency’s ongoing prioritization of digital health regulatory development.

All three guidances stem from 21st Century Cures Act requirements for faster and more efficient medical technology development and market authorization. The guidances include:

  • Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act: draft guidance  that covers US regulatory policies for low-risk devices, mobile medical apps, off-the-shelf software components of devices and medical device data systems
  • Clinical and Patient Decision Support Software: draft guidance explaining which types of clinical decisions support software fall under FDA oversight based on 21st Century Cures Act requirements
  • Software as a Medical Device: Clinical Evaluation: final guidance on principles for clinical evaluation of software as a medical device (SaMD), based on the agency’s work with the International Medical Device Regulators Forum (IMDRF); draft guidance on SaMD was issued in October 2016.

Emergo will publish in-depth analyses of these guidances in the near future.

Related US FDA regulatory resources from Emergo:

  • FDA registration consulting for medical device and IVD companies
  • Regulatory consulting for mobile medical apps and telehealth products
  • Cybersecurity support for network-connected software and devices
  • Whitepaper: Wearables versus regulated medical devices


  • Stewart Eisenhart