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Regulatory and policy corner
Market competition among manufacturers of novel high-risk therapeutic devices receiving FDA premarket approval between 2001 and 2018

Authors

  • Vinay K Rathi Department of Otolaryngology – Head and Neck Surgery, Massachusetts Eye and Ear, Boston, Massachusetts, USA PubMed articlesGoogle scholar articles
  • James L Johnston Department of Medicine, Brigham and Women’s Hospital, Boston, Massachusetts, USA PubMed articlesGoogle scholar articles
  • Sanket Dhruva Department of Medicine, University of California San Francisco School of Medicine, San Francisco, California, USASan Francisco Veterans Affairs Health Care System, San Fransisco, California, USA PubMed articlesGoogle scholar articles
  • Joseph Ross Department of Medicine, Yale University School of Medicine, New Haven, Connecticut, USACenter for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut, USADepartment of Health Policy and Management, Yale School of Public Health, New Haven, Connecticut, USAYale National Clinician Scholars Program, Yale School of Medicine, New Haven, Connecticut, USA PubMed articlesGoogle scholar articles
  1. Correspondence to Dr Vinay K Rathi; vinay_rathi{at}meei.harvard.edu

Citation

Rathi VK, Johnston JL, Dhruva S, et al
Market competition among manufacturers of novel high-risk therapeutic devices receiving FDA premarket approval between 2001 and 2018
BMJ Surgery, Interventions, & Health Technologies 2023;5:e000152. doi: 10.1136/bmjsit-2022-000152

Publication history

  • First published February 8, 2023.
Online issue publication 
February 08, 2023

  • Supplementary Data

    This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.

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© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ. http://creativecommons.org/licenses/by-nc/4.0/This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.