As technology advances all facets of health care, software has become an essential part of many products and is integrated widely into medical devices. The FDA recognizes this evolving landscape and seeks to provide our latest thinking on regulatory considerations for device software functions aligned with current standards and best practices.

Read the full press release here: https://www.fda.gov/news-events/press-announcements/fda-brief-fda-provides-new-draft-guidance-premarket-submissions-device-software-functions