Manufacturers of dermatologic devices have been shown to increasingly modify those devices via the use of supplemental pathways that require minimal supporting clinical data, resulting in inadequately studied modifications that may influence the safety and effectiveness of these devices, according to the results of a cross-sectional, retrospective cohort database analysis recently published in JAMA Dermatology.
When the US Food and Drug Administration (FDA) approves Class III medical devices via the premarket approval (PMA) process, clinical data on safety and efficacy are often required. When manufacturers submit incremental device changes via supplemental applications, they are not subject to such vetting measures.
The study investigators sought to characterize the postapproval changes to Class III dermatologic devices and to assess inconsistencies in the utilization of the PMA pathway. They conducted an analysis of a public US FDA database for PMA approval of such devices between January 1, 1980 and November 1, 2016.
A total of 27 dermatologic devices were evaluated, including 14 injectables (implants or fillers; 51.9%), 11 photodynamic therapy devices (40.7%), 1 dermal replacement matrix (3.7%), and 1 diagnostic imaging instrument (3.7%).
Overall, a total of 562 PMA supplements were approved for the 27 dermatologic devices assessed. Of these supplements, 83.1% (467 of 562) were for implants or fillers, 8.2% (46 of 562) were for dermal replacement devices, 6.6% (37 of 562) were for photodynamic therapies, and 2.1% (12 of 562) were for diagnostic imaging devices.
Regarding the increasing use of supplemental applications, the researchers reported that the data-requiring panel-track pathway was the least common approach, being used in 2.8% (16 of 562) of supplements, whereas the 30-day track, which does not require any clinical data, was used in 42.5% (239 of 562) of supplements and was the most common approach. Overall, 14.8% (4 of 27) of the devices underwent low-risk recalls (Class II or Class III), and 37.0% (10 of 27) were voluntarily withdrawn.
The investigators concluded that greater transparency and higher review standards may help to improve inconsistencies in the use of PMA pathways for the approval of dermatologic devices. The use of such enhancements will permit improved evaluation of the safety and efficacy of device modification.
Ezaldein HH, Scott JF, Yin ES, Ventura A, DeRuyter NP, Leffell DJ. Transparency and dermatologic device approval by the US Food and Drug Administration [published online January 24, 2018]. JAMA Dermatol. doi:10.1001/jamadermatol.2017.5757