Home Access' OTC HIV testing service sales may be delayed in California, New York.
This article was originally published in The Tan Sheet
Executive Summary
HOME ACCESS' OTC HIV TESTING SERVICE SALES MAY BE DELAYED in New York and California, two of the largest markets for the product, due to clinical testing requirements in the two states. Home Access Health submitted a request for an "expedited advisory opinion" to FDA on Aug. 16 seeking a determination that the agency's premarket approval of the tests preempts the state requirements.