Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assay Devices, Renamed to Hepatitis C Virus Antibody Tests
fda-device · Food and Drug Administration · Rule · Published 2021-11-22 · Effective 2021-12-22 · 86 FR 66173
Document
Document number
2021-25374
Federal Register citation
86 FR 66173
CFR reference
21 CFR 866
Type
Rule
Action
Final amendment; final order.
Category
fda-device
Sub-agency
Food and Drug Administration
Publication date
2021-11-22
Effective date
2021-12-22
HHS docket
Docket No. FDA-2020-N-1082
Abstract
The Food and Drug Administration (FDA or the Agency) is issuing a final order 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 renaming and codifying these devices under the classification regulation named "hepatitis C virus (HCV) antibody tests." FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of these devices.