title: Postmarket Modifications of High-Risk Therapeutic Devices in Otolaryngology Cleared by the US Food and Drug Administration.
abstract: OBJECTIVE
  The US Food and Drug Administration (FDA) grants initial marketing clearance for novel high-risk medical devices via the premarket approval (PMA) pathway, which requires clinical data demonstrating safety and effectiveness. Manufacturers may subsequently file supplemental PMA applications (supplements) to implement incremental device changes, usually without additional clinical data. Given the potentially significant clinical implications of using new device models, this study characterized the frequency and nature of changes to high-risk therapeutic otolaryngic devices cleared via the PMA pathway.
  
  
  METHODS
  Retrospective cohort study.
  
  
  METHODS
  FDA PMA database.
  
  
  METHODS
  Original high-risk therapeutic otolaryngic devices and supplements were identified. Supplements were characterized by clearance date, change type, and review track, including real-time (design-minor) and 180-day (design-major) tracks. Median device lineage life span (postmarket period over which changes occurred) and median number of changes per original device were calculated.
  
  
  RESULTS
  Through 2014, the FDA cleared 14 original high-risk therapeutic otolaryngic devices via the PMA pathway and 528 incremental changes via supplements. Devices were modified over a median 10.5-year life span (interquartile range, 4.4-15.8; range, 0.7-24.1), and they underwent a median 22 changes (interquartile range, 10-70; range, 2-108). Over half (272 of 528; 52%) altered device design, most of which were reviewed via the 180-day track (199 of 272; 73%) intended for major design changes. Few real-time design changes (11 of 73; 15%) were designated by the FDA as "minor."
  
  
  CONCLUSIONS
  A substantial number of incremental changes have been made to high-risk therapeutic otolaryngic devices over time, including many major design changes without supporting clinical data.
authors.affiliation: Yale University School of Medicine, New Haven, Connecticut Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut.
authors.forename: Vinay K
authors.initials: VK
authors.lastname: Rathi
authors.affiliation: Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, Connecticut Robert Wood Johnson Clinical Scholars Program, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut Section of Health Policy and Administration, Department of Epidemiology and Public Health, Yale University School of Medicine, New Haven, Connecticut Section of General Internal Medicine, Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Joseph S
authors.initials: JS
authors.lastname: Ross
authors.affiliation: Yale University School of Medicine, New Haven, Connecticut.
authors.forename: Andre M
authors.initials: AM
authors.lastname: Samuel
authors.affiliation: Department of Surgery (Otolaryngology), Yale University School of Medicine, New Haven, Connecticut, New Haven, Connecticut saral.mehra@yale.edu.
authors.forename: Saral
authors.initials: S
authors.lastname: Mehra
mesh_terms: D018795:Device Approval; D004869:Equipment Safety; D006801:Humans; D010036:Otolaryngology / Q000295:instrumentation*; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies; D014481:United States; D014486:United States Food and Drug Administration
keywords: medical device; otolaryngology; postmarket; premarket approval