Over the past several years, there have been a number of regulatory developments related to digital health, including the 21st Century Cures Act, FDARA, and an ever-increasing amount of FDA guidance documents. This panel will discuss FDA’s proposed changes to how it regulates digital health products, the status of the precertification pilot, whether and how FDA can implement these significant changes without additional legislative changes, and what the new programs mean for digital health developers, consumers, and the healthcare system.
Mark R. Dahlby, FDA Regulatory and Healthcare Compliance Counsel, IBM
Jeffrey N. Gibbs, Director, Hyman, Phelps & McNamara, PC, and Chair, FDLI Board of Directors
Bakul Patel, Associate Director for Digital Health, CDRH, FDA
Moderated by Nancy Stade, Partner, Sidley Austin LLP