Business · 11/05/2011

FDA Releases Draft Guidance for In Vitro Diagnostic Devices for Chlamydia and Gonorrhea Testing

The FDA has made available a draft guidance document outlining recommendations for the performance characteristics of in vitro diagnostic devices for screening and diagnostic testing of Chlamydia trachomatis and/or Neisseria gonorrhoeae, with the goal of improving the accuracy and effectiveness of these tests.