FDA Faults SmartPractice Denmark For Misleading Allergy Test Promotion

The Food and Drug Administration has told SmartPractice Denmark AS that promotional materials for T.R.U.E. Test (thin-layer rapid use epicutaneous patch test) are false or misleading because they omit risk information, according to a warning letter posted May 14 on FDA’s website.

FDA also said the promotional materials appear to have been disseminated without adequate directions for use. The agency also said the company failed to submit the promotional materials to FDA at the time of initial distribution.

T.R.U.E. Test is indicated as an aid in the diagnosis of allergic contact dermatitis in patients at least 18 years old whose ...