Under the 21st Century Cures legislation, there are five categories of software excluded from the definition of a “device”. What was the intent of these provisions, where is FDA on implementing these carveouts, and is FDA taking actions intended under the legislation? If not, what can or should FDA be doing differently? During this session, speakers will discuss these topics, whether FDA has the authority needed to properly regulate new technologies, their perspectives on recent and upcoming legislation, and more.
On November 9, 2021, Morrison & Foerster partner Stacy Amin will moderate the panel, “Congressional Perspectives in Digital Health" from 4:45 – 5:45 PM ET at the Food and Drug Institute’s Digital Health Technology and Regulation Virtual Conference.
On November 10, 2021, Morrison & Foerster partner Bethany Hills will participate in the panel discussion, “Telehealth 2021: Regulatory and Reimbursement Developments” from 2:15 – 3:00 PM ET at the virtual conference.