On Nov. 19, the US Food and Drug Administration (FDA) offered a measure of regulatory relief to producers of hepatitis C virus (HCV) tests by reclassifying certain HCV tests from Class III to Class II. Result: The reclassified tests will now be able to reach the market via 510(k) clearance instead of the premarket approval (PMA) pathway. The HCV Tests Reclassification Order The FDA classifies medical devices based on their risk to consumers. Because they are considered to carry the least risk, Class I devices are subject to the least stringent regulatory requirements. Class III devices are considered to have the highest risk and must pass through PMA, the agency’s most rigorous form of device review. The newly announced reclassification applies to nucleic acid-based hepatitis C ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, as well as to certain hepatitis C antibody devices intended for the qualitative detection of the virus. “The reclassification may support the potential for more manufacturers to develop these tests, which can increase competition and increase access to these important tests,” noted the statement from Timothy Stenzel, director of the FDA Office of In Vitro Diagnostics and Radiological […]