US FDA News: FDA In Brief: FDA Issues Final Orders Reclassifying Certain Hepatitis C Diagnostic Tests from Class III to Class II

Today, the FDA issued two final orders, reclassifying certain HCV diagnostic tests from class III to II. These orders allow these HCV tests to use FDA’s 510(k) pathway rather than the PMA pathway.
Read more: FDA In Brief: FDA Issues Final Orders Reclassifying Certain Hepatitis C Diagnostic Tests from Class III to Class II