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. 2018 Mar 1;154(3):273-280.
doi: 10.1001/jamadermatol.2017.5757.

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

Harib H Ezaldein  1   2   3 , Jeffrey F Scott  3 , Emily S Yin  1 , Alessandra Ventura  1   4 , Nicholaas P DeRuyter  2 , David J Leffell  1
Affiliations

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

Harib H Ezaldein et al. JAMA Dermatol. .

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 Four devices (14.8%) underwent low-risk recalls (Class II or Class III), and 10 devices (37.0%) were voluntarily withdrawn.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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Conflict of interest statement

Conflict of Interest Disclosures: None reported.

Figures

Figure 1.
Figure 1.. Statistical Trends in Device Approvals and Supplement Use
A, Original Class III device approval rates show no observable trend over the study period (January 1980-November 2016). B, Supplement use during the same period has statistically significantly increased, with a stronger observable trend over the past decade. PMA indicates premarket approval.
Figure 2.
Figure 2.. Postmarked Modifications per Approved Dermatologic Device
Class III devices are ordered chronologically by date of original premarket approval (PMA) application. Injectable agents undergo a larger number of supplement routes that require minimal clinical effectiveness data. Panel track and 180-day tracks, which require such studies, are less commonly used compared with earlier devices. Lasers and photodynamic therapies are observed to have lesser postmarket modifications compared with injectables.
Figure 3.
Figure 3.. Types of Changes in Dermatologic Devices by Supplement Track
Unclassified supplements are not included in this graph. A sizable proportion of the 180-day track supplements are used by manufacturing changes, rather than design and labeling changes. A significant level of the real-time process applications was approved for labeling and manufacturing changes, rather than its intended use for minor design modifications. Panel track and special (immediate track) supplements were used for labeling changes, with few exceptions. Last, 30-day and 135-day tracks were appropriately used for manufacturing changes. ODE indicates Office of Device Evaluation; OIR, Office of In Vitro Diagnostics and Radiological Health; OSB, Office of Surveillance and Biometrics; PAS, postapproval study; and PMA, premarket approval.
Figure 4.
Figure 4.. Postmarket Modification Trends Over Time
Over time, the overall share of supplements subjected to 180-day review tracks has decreased. The introduction of the 30-day and 135-day and real-time tracks in 1997 resulted in an increased popularity of their use and overall number of postmarket modifications per device. Panel-track supplements remain rarely used. PMA indicates premarket approval.
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Comment in

  • doi: 10.1001/jamadermatol.2017.5758

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