Approval of New Patch Tests for the Diagnosis of Allergic Contact Dermatitis: An FDA Public Workshop

This is the authors' abstract. We don't add key points for this paper.

Contact dermatitis (CD) is the 5th most common skin disease1 and affects 15-20% of the general population over their lifetimes.2 Currently, the T.R.U.E. TEST® is the only FDA-approved diagnostic product to aid in the diagnosis of Allergic Contact Dermatitis. To address that diagnostic gap, the US Food and Drug Administration held a public workshop in October 2025. These proceedings summarize the workshop presentations and discussions.