Hepatitis C virus (HCV) antibody assay devices; Medical equipment (ICS 11.040), Laboratory medicine (ICS 11.100)

Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assays Devices, To Be Renamed Hepatitis C Virus Antibody Tests (7 page(s), in English)

Proposed amendment; proposed order; request for comments - The Food and Drug Administration (FDA or Agency) is proposing to reclassify certain hepatitis C virus (HCV) antibody assay devices intended for the qualitative detection of HCV, postamendments class III devices (product code MZO) into class II (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "hepatitis C virus (HCV) antibody tests" along with the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for these devices. FDA is proposing this reclassification on its own initiative. If finalized, this order will reclassify these types of devices from class III (general controls and premarket approval) to class II (general controls and special controls) and reduce the regulatory burdens associated with these devices, as these types of devices will no longer be required to submit a premarket approval application (PMA), but can instead submit a premarket notification under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and obtain clearance before marketing their device.