2020-06820. Microbiology Devices; Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, To Be Renamed Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid 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:
2020-06820
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:
18483-18490 (8 pages)
Docket Numbers:
Docket No. FDA-2020-N-1088
SectionNoes:
866.3170
Topics:
Biologics, Laboratories, Medical devices
PDF File:
2020-06820.pdf
Supporting Documents:
» Reference 7 - Ioannou et al Journal of Hepatology 2018 re Microbiology Devices; Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, To Be Renamed Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests
» Reference 6 - Moorman et al Heptaology 2015 re Microbiology Devices; Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, To Be Renamed Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests
» Reference 5 - Aisyah et al Journal Viral Hep 2018 re Microbiology Devices; Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, To Be Renamed Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests
CFR: (1)
21 CFR 866.3170