FDA is proposing to reclassify certain Hepatitis C (HCV) diagnostic tests from class III to II. Once finalized, tests of this type and use will go through FDA ’ s 510(k) pathway. Learn more: https://go.usa.gov/xvCuw   & https://go.usa.gov/xvCuH   pic.twitter.com/UXLETnMnJj

FDA is proposing to reclassify certain Hepatitis C (HCV) diagnostic tests from class III to II. Once finalized, tests of this type and use will go through FDA’s 510(k) pathway. Learn more: https://go.usa.gov/xvCuw  & https://go.usa.gov/xvCuH  pic.twitter.com/UXLETnMnJj

Source: Food and Drug Adminstration (FDA): CDRHNew - April 1, 2020 Category: Medical Devices Authors: ( at US_FDA) Source Type: news