Optical Cervical Cancer Detection Devices Draft Guidance Reissued May 24
This article was originally published in The Gray Sheet
Executive Summary
Test data that both demonstrates the biocompatibility of materials used at the device/cervix interface and characterizes the foreseeable hazards posed by optical radiation or thermal effects must be provided by companies seeking to market devices for the optical detection of cervical cancer and its precursors, FDA says in a draft guidance released May 24 on the agency's website.