FDA Creates a New Center for Digital Health Products
(Thursday, September 24, 2020]​
This week FDA announced a new Digital Health Center of Excellence within CDRH with an explicit mandate to provide advice and support to developers of digital health products. The Center would consolidate FDA resources to create policies and support infrastructure for review of software and digital health products, address cybersecurity issues, evaluate tools based on artificial intelligence and machine leaning, manufacturing automation involving computerized technology, big data analysis algorithms, and interact with developers to discuss their products prior to and during formal interactions with the indication-specific review divisions. The immediate plan of the Center is to raise awareness and engage internal experts about the FDA mission to encourage digital health. Later this year, the Center plans to reach out to industry stakeholders, many of who have already been interacting with FDA over the last few years to create digital health communities, and advisory groups. The Center will play a supportive role and will not lead the review of a given product, but it would be fair to expect it to play an increasingly bigger role over the years in FDA’s overall decisions regarding digital health products. The best way for the industry to take advantage of this initiative is to directly contact the center to initiate discussions.