title: Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.
abstract: BACKGROUND
  In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway.
  
  
  RESULTS
  We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions.
  
  
  CONCLUSIONS
  Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.
authors.affiliation: Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Ross
authors.affiliation: Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.
authors.forename: Katrina L
authors.initials: KL
authors.lastname: Blount
authors.affiliation: Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.
authors.forename: Jessica D
authors.initials: JD
authors.lastname: Ritchie
authors.affiliation: Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.
authors.forename: Beth
authors.initials: B
authors.lastname: Hodshon
authors.affiliation: Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA.
authors.forename: Harlan M
authors.initials: HM
authors.lastname: Krumholz
keywords: FDA; PMA pathway; post-market surveillance