Discussion on "Approval policies for modifications to machine learning-based software as a medical device: A study of bio-creep" by Jean Feng, Scott Emerson, and Noah Simon.

Abstract

Authors

• Gene Pennello
  Division of Imaging, Diagnostics, and Software Reliability, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland, USA.
• Berkman Sahiner
  Food and Drug Administration/CDRH, Silver Spring, USA.
• Alexej Gossmann
  Division of Imaging, Diagnostics, and Software Reliability, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, Food and Drug Administration, Silver Spring, Maryland, USA.
• Nicholas Petrick

Keywords

External Resources