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2020-04-02
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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
Proposed Rules
D09002ee1bdb5ae3c
D09002ee1bdb5aeb7
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is proposing to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, postamendments class III devices (product codes MZP and OBF), into class II (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name ``nucleic acid-based Hepatitis C virus (HCV) ribonucleic acid 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 (510(k)) and obtain clearance before marketing their device.
85 FR 18483
https://www.govinfo.gov/app/details/FR-2020-04-02/2020-06820
2020-06820
fr02ap20-20
4164-01-P
Docket No. FDA-2020-N-1088
https://www.govinfo.gov/app/details/FR-2020-04-02/2020-06820
https://www.govinfo.gov/content/pkg/FR-2020-04-02/html/2020-06820.htm
https://www.govinfo.gov/content/pkg/FR-2020-04-02/pdf/2020-06820.pdf
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Laboratories
Medical Devices
8 p.
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85 FR 18483
Code of Federal Regulations
Title 21 Part 866
21 CFR Part 866
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; Federal Register Vol. 85, Issue
PRORULE
2020-06820
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2020-06-01
Docket No. FDA-2020-N-1088
4164-01-P
2020-06820
Proposed amendment; proposed order; request for comments.
The Food and Drug Administration (FDA or Agency) is proposing to reclassify nucleic acid-based hepatitis C virus (HCV) ribonucleic acid (RNA) devices intended for the qualitative or quantitative detection or genotyping of HCV RNA, postamendments class III devices (product codes MZP and OBF), into class II (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name ``nucleic acid-based Hepatitis C virus (HCV) ribonucleic acid 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 (510(k)) and obtain clearance before marketing their device.
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.
Silke Schlottmann, Division of Microbiology Devices, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3258, Silver Spring, MD 20993-0002, 301-796-9551, silke.schlottmann@fda.hhs.gov.
Biologics
Laboratories
Medical Devices
silke.schlottmann@fda.hhs.gov
https://www.fda.gov/media/111502/download
https://www.fda.gov/media/119966/download
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/deciding-when-submit-510k-change-existing-device
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.hhs.gov/sites/default/files/National%20Viral%20Hepatitis%20Action%20Plan%202017-2020.pdf
https://www.regulations.gov
Federal Register
Vol. 85, no. 64
Office of the Federal Register, National Archives and Records Administration
2020-04-02
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2020-04-02
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https://www.govinfo.gov/content/pkg/FR-2020-04-02/pdf/FR-2020-04-02.pdf
https://www.govinfo.gov/content/pkg/FR-2020-04-02/xml/FR-2020-04-02.xml
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