Skip To The Main Content

FDA Issues Guidance on Digital Health and Testimony to Congress on Implementation of the 21st Century Cures Act

The United States Food and Drug Administration (FDA) has issued three new guidance documents on digital health: 1) Changes to Existing Medical Software Policies Resulting from Section 3060 of the 21st Century Cures Act; 2) Clinical and Patient Decision Support Software; and 3) Software as a Medical Device: Clinical Evaluation.  You can read the complete FDA guidance documents on digital health by clicking on the three listed individual documents.  In addition, the FDA testified before Congress on its related efforts to implement the 21st Century Cures Act and has made that testimony available to the public.  To read the FDA announcement and summary of the three new guidance documents on digital health, use the first link below.  To read the statement of the FDA Commissioner on the new digital health guidance documents, use the second link below.  To read the FDA testimony to Congress on its implementation of the 21st Century Cures Act, use the last link below.
http://s2027422842.t.en25.com/e/es?s=2027422842&e=27694&elqTrackId=B1F0B909CCF90C71B9C490C37BFE6647&elq=816131a214204a3ebe37976b78dc01b1&elqaid=1674&elqat=1  (FDA announcement and summary of digital health guidance documents)
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm587890.htm?utm_campaign=12072017_Statement_Advancing%20digital%20health%20policies&utm_medium=email&utm_source=Eloqua  (FDA Commissioner statement on digital health guidance documents)
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm588046.htm?utm_campaign=12072017_Statement_Commissioner%20remarks%20Senate%20HELP%20hearing%2021st%20century%20cures%20act&utm_medium=email&utm_source=Eloqua  (FDA testimony to Congress on implementation of the 21st Century Cures Act)
"State":"NY"