Final Order: Hepatitis C Virus Diagnostic Tests

The Final Order reclassifies two types of HCV diagnostic tests from class III to class II

If your email program has trouble displaying this email, view as a webpage. FDA Issues Final Orders Reclassifying Two Types of Hepatitis C Virus Diagnostic Tests Today, the U.S. Food and Drug Administration (FDA) issued final orders to reclassify two types of hepatitis C virus (HCV) diagnostic tests from class III to II. With these final orders, devices of these types may go through the FDA's 510(k) pathway for clearance instead of the premarket approval (PMA) pathway. Class II devices are required to comply with special controls to provide a reasonable assurance of safety and effectiveness. These final orders provide the special controls, that in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these HCV tests. These two types of HCV tests are reclassified: Nucleic acid-based HCV ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA (product codes MZP and OBF). Certain HCV antibody devices intended for the qualitative detection of antibodies to HCV (product code MZO). Read More Questions? If you have questions, contact the Division of Industry and Consumer Education.

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