UCSF CENTER FOR DIGITAL HEALTH INNOVATION’S COMMENTS ON VERSION 1.0 OF FDA’S DRAFT SOFTWARE PRECERTIFICATION PROGRAM WORKING MODEL, FILE NO. FDA-2017-N-4301-0001

The University of California, San Francisco’s Center for Digital Health Innovation submits these comments on the Food and Drug Administration’s draft Software Precertification Program Working Model, version 1.0, issued January 7, 2019. The University of California, San Francisco (UCSF) is a worldwide leader in health care delivery, discovery, and education, with a mission of “Advancing Health Worldwide.” Consistent with this public imperative, UCSF invests heavily in developing a variety of health information technology, innovation, and management resources and best practices to give health care providers and patients,1 researchers and scientists, educators and students the digital diagnostic and therapeutic tools such as software as a medical device to succeed in this rapidly evolving digital health age. We thank you for the opportunity to provide these comments.