FDAnews Device Daily Bulletin

Clinical Site’s Problems Won’t Trip Up Launch of First HIV Home Test

Aug. 16, 2012
An FDA warning letter issued to a researcher involved in clinical trials of the first home HIV test is not expected to affect the product’s marketing, officials from the FDA and the test’s manufacturer said. OraSure Technologies’ OraQuick HIV home test was approved by the FDA last month and is expected to hit retail outlets nationwide in October.
Devices & Diagnostics Letter