Fostering Digital Health Innovation: Developing the Software Precertification Program Day 2

The Food and Drug Administration (FDA), is announcing the following public workshop entitled "Fostering Digital Health Innovation: Developing the Software Precertification Program.” The purpose of the public workshop is to discuss the progress of the pilot precertification program and to seek input on the ongoing development of the Software Precertification Program. In its Digital Health Innovation Action Plan and as part of the Medical Device User Fee Amendments, FDA has committed to explore opportunities to establish streamlined regulatory pathways tailored for digital health technologies that take in to account real world evidence while incorporating principles established through international harmonization.