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.

Gene Pennello Berkman Sahiner Alexej Gossmann Nicholas Petrick

Biometrics

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.

Published: March 2021

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http://dx.doi.org/10.1111/biom.13381	DOI Listing

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