No abstract

HIV self-testing has emerged as a tool to increase the proportion of people to know their status. Since the first HIV self-test was approved in 2012 by the FDA, global access to HIV self-tests has been bolstered by public-private partnerships to ensure equitable access in low- and middle-income countries (LMICs). However, no company has applied for FDA clearance in a decade. We highlight the potential benefits to reclassifying HIV self-tests from class III to class II.