2020-06821. Microbiology Devices; Reclassification of Certain Hepatitis C Virus Antibody Assays Devices, To Be Renamed Hepatitis C Virus Antibody Tests  

Document Information

Published:
04/02/2020
Department:
Health and Human Services Department
Agency:
Food and Drug Administration
EntryType:
Proposed Rule
Action:
Proposed amendment; proposed order; request for comments.
Document Number:
2020-06821
Dates:
Submit either electronic or written comments on the proposed order by June 1, 2020. Please see section XI of this document for the proposed effective date when the new requirements apply and for the proposed effective date of a final order based on this proposed order.
Pages:
18490-18496 (7 pages)
Docket Numbers:
Docket No. FDA-2020-N-1082
SectionNoes:
866.3169
Topics:
Biologics, Laboratories, Medical devices
PDF File:
2020-06821.pdf
CFR: (1)
21 CFR 866.3169