CommentaryFood and Drug Administration Guidance Documents and New Medical Devices: The Case of Breast ProsthesesWeitzman, Rachel E. MS1; Stern, Ariel D. PhD2; Kramer, Daniel B. MD, MPH1,3,*Author Information 1Harvard Medical School, Boston, MA; 2Harvard Business School, Boston, MA; and 3The Richard A. and Susan F. Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA. *Address for correspondence: Daniel B. Kramer, 375 Longwood Avenue, Suite 440, Boston, MA 02215. E-mail: [email protected] D.B. Kramer is supported by the Greenwall Faculty Scholars Program and is a consultant to the Circulatory Systems Advisory Panel of the Food and Drug Administration. The remaining authors have no conflicts of interest to declare. American Journal of Therapeutics: January/February 2021 - Volume 28 - Issue 1 - p e127-e130 doi: 10.1097/MJT.0000000000000888 Buy Metrics Copyright © 2018 Wolters Kluwer Health, Inc. All rights reserved.