Business · 05/01/2011

FDA Releases Draft Guidance for Nucleic Acid-Based Diagnostic Devices for MRSA and Staphylococcus aureus

The FDA has released a draft guidance document outlining updated recommendations for the analytical and clinical performance of nucleic acid-based in vitro diagnostic devices for detecting and differentiating methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA).