June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Modifications to High-Risk Ophthalmic Devices Following Initial FDA Premarket Approval, 1979-2015
Author Affiliations & Notes
  • Anand Gopal
    Department of Ophthalmology and Visual Science, Yale University School of Medicine, New Haven, Connecticut, United States
  • Vinay K. Rathi
    Department of Otolaryngology, Massachusetts Eye and Ear Infirmary, Boston, Massachusetts, United States
  • Christopher Teng
    Department of Ophthalmology and Visual Science, Yale University School of Medicine, New Haven, Connecticut, United States
  • Lucian V Del Priore
    Department of Ophthalmology and Visual Science, Yale University School of Medicine, New Haven, Connecticut, United States
  • Joseph S. Ross
    Department of Internal Medicine, Yale University School of Medicine, New Haven, Connecticut, United States
  • Footnotes
    Commercial Relationships   Anand Gopal, None; Vinay Rathi, None; Christopher Teng, None; Lucian Del Priore, None; Joseph Ross, Blue Cross Blue Shield Association (F), Centers for Medicare and Medicaid Services (F), Food and Drug Administration (F), Johnson & Johnson (F), Laura and John Arnold Foundation (F), Medtronic, Inc. (F)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 5077. doi:
  • Views
  • Share
  • Tools
    • Alerts
      ×
      This feature is available to Subscribers Only
      Sign In or Create an Account ×
    • Get Citation

      Anand Gopal, Vinay K. Rathi, Christopher Teng, Lucian V Del Priore, Joseph S. Ross; Modifications to High-Risk Ophthalmic Devices Following Initial FDA Premarket Approval, 1979-2015. Invest. Ophthalmol. Vis. Sci. 2017;58(8):5077.

      Download citation file:


      © ARVO (1962-2015); The Authors (2016-present)

      ×
  • Supplements
Abstract

Purpose : Manufacturers of high-risk ophthalmic devices approved via the U.S. Food and Drug Administration (FDA) Premarket Approval (PMA) pathway may seek approval for postmarket device modifications by submitting PMA supplements. Unlike traditional PMAs, most supplements do not require new clinical data, despite sometimes significant changes to device design. This study characterized the frequency and means by which high-risk ophthalmic devices are incrementally altered following initial approval and tested the hypothesis that recalled devices undergo more postmarket modifications than non-recalled devices.

Methods : We performed a retrospective analysis of high-risk ophthalmic device supplement approvals using FDA’s PMA Database. We characterized initial approvals and supplement type. We calculated median iterated lifespan as well as median number of supplements approved per device. The FDA Recall Database was used to identify safety events. We used the Wilcoxon rank-sum test to compare the median number of supplements between recalled and non-recalled devices.

Results : Through 2015, FDA approved 168 original ophthalmic devices via the PMA pathway and 2,813 associated modifications. Most devices (86%) underwent multiple post-approval revisions, including multiple design changes (50%). Devices underwent a median of 11 postmarket changes (IQR, 3-24.8) across a median 10.0-year iterated-lifespan (IQR, 4.1-16.7). Median number of design/labeling changes per device was 3.5 (IQR, 1-9). While process alterations (834 of 2813; 30%) were the most frequent type of revision, device design (667; 24%) and labeling changes (417; 15%) were common, though just 5.4% of these (59 of 1084) were definitively approved on the basis of clinical evidence. Devices experiencing clinically significant recalls (Class I or II) underwent more supplements than non-recalled devices (p = 0.004).

Conclusions : High-risk ophthalmic devices have undergone serial revisions, including substantial design and labeling changes, since initial approval, often without supporting clinical data. Ophthalmologists should take into consideration that cumulative revisions may impact device safety and performance, as recalled devices underwent a greater number of modifications than non-recalled devices.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

 

Distribution of postmarket events occurring across the lifetime of high-risk ophthalmic devices approved via FDA’s PMA pathway since initial approval.

Distribution of postmarket events occurring across the lifetime of high-risk ophthalmic devices approved via FDA’s PMA pathway since initial approval.

×
×

This PDF is available to Subscribers Only

Sign in or purchase a subscription to access this content. ×

You must be signed into an individual account to use this feature.

×