Digital health technologies are moving forward toward rapid adoption in the United States. Yet, software developers are often apprehensive about the often long and detailed process of FDA’s premarket review. FDA’s new Digital Health Software Precertification (Precert) Program (“Precert Program”), announced in August 2017 (see our previous post here), seeks to pilot a “fast-track” process for developers of software-as-a-medical device that the FDA trusts to produce consistently high quality, safe and secure products, removing the necessity to undergo the full-blown design and validation review for each new software product.
Continue reading FDA’s Digital Health Software Precertification (Precert) Program at FDA Law Blog.