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Original Investigation
March 2018

Transparency and Dermatologic Device Approval by the US Food and Drug Administration

Author Affiliations
  • 1Department of Dermatology, Yale School of Medicine, New Haven, Connecticut
  • 2Department of Surgery, University of Washington, Seattle
  • 3Department of Dermatology, University Hospitals Cleveland Medical Center, Cleveland, Ohio
  • 4Dermatology Department, University of Rome Tor Vergata, Rome, Italy
JAMA Dermatol. 2018;154(3):273-280. doi:10.1001/jamadermatol.2017.5757
Key Points

Question  What postapproval changes occur to Class III dermatologic devices approved by the US Food and Drug Administration via the premarket approval pathway?

Findings  In this cross-sectional database study of 27 dermatologic devices, manufacturers are shown to increasingly modify devices via supplement pathways that require minimal supporting clinical data.

Meaning  Postapproval changes to Class III dermatologic devices may result in inadequately studied modifications that could influence device effectiveness and safety.

Abstract

Importance  The US Food and Drug Administration approves Class III medical devices via the premarket approval pathway, often requiring clinical data on safety and efficacy. Manufacturers can submit incremental device changes via supplemental applications, which are not subjected to such vetting measures and can cause understudied changes that lead to drift from a device’s original design.

Objectives  To characterize the postapproval changes to Class III dermatologic devices and to evaluate inconsistencies in the use of the premarket approval pathway.

Design, Setting, and Participants  This study was a cross-sectional retrospective cohort analysis of a public US Food and Drug Administration database for premarket approval of devices. Included were dermatologic devices approved by the US Food and Drug Administration between January 1, 1980, and November 1, 2016, through the premarket pathway for device approval.

Main Outcomes and Measures  Original devices were identified, and their supplements were characterized chronologically, by review track, and by modification category.

Results  The 27 dermatologic devices studied consisted of 14 injectables, 11 photodynamic therapies, a dermal replacement matrix, and a diagnostic imaging instrument. Supplemental applications are increasingly used: the data-requiring panel-track pathway was the least common approach (2.8% [16 of 562 supplements]), while the 30-day track, which does not require clinical data, was most frequently used (42.5% [239 of 562 supplements]). Four devices (14.8%) underwent low-risk recalls (Class II or Class III), and 10 devices (37.0%) were voluntarily withdrawn.

Conclusions and Relevance  As manufacturers make increasing use of supplemental applications, minor device changes may occur without supporting clinical data, which could pose a safety risk to patients.

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