Diane Johnson, MS

Digital Health Policy Lead
Johnson & Johnson

Diane Johnson is responsible for regulatory policy shaping for North America for the Johnson & Johnson Medical Device Companies, as well as serving as the regulatory Digital Health Policy Lead. She is the Johnson & Johnson DRI for the FDA Software Precertification Pilot. She is responsible for identifying key emerging regulatory policy issues and shaping the outcomes through continued interactions with HAs. She has over 30 years of experience in the device industry, specializing predominantly in Regulator Affairs. For five years, she was a senior scientific reviewer at FDA’s CDRH, with a focus on cardiovascular devices. Her B.S. and MS. are in Materials Engineering.

Presentation(s):

• FDA’s New Approaches to Software Regulation: Pre-Certification and Artificial Intelligence

  Tuesday, September 24
  9:15 AM – 10:30 AM