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2020-09-18
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Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management, To Be Renamed Quantitative Cytomegalovirus Nucleic Acid Tests for Transplant Patient Management
Proposed Rules
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D09002ee1bdb389e7
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or the Agency) is proposing to reclassify cytomegalovirus (CMV) deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management, a postamendments class III device (product code PAB) into class II (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name ``quantitative cytomegalovirus (CMV) nucleic acid tests for transplant patient management'' to identify these devices along with the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for the device. 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 manufacturers of 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 58300
https://www.govinfo.gov/app/details/FR-2020-09-18/2020-20716
2020-20716
fr18se20-20
4164-01-P
Docket No. FDA-2016-N-2880
https://www.govinfo.gov/app/details/FR-2020-09-18/2020-20716
https://www.govinfo.gov/content/pkg/FR-2020-09-18/html/2020-20716.htm
https://www.govinfo.gov/content/pkg/FR-2020-09-18/pdf/2020-20716.pdf
Biologics
Laboratories
Medical Devices
8 p.
58300
58307
85 FR 58300
Code of Federal Regulations
Title 21 Part 866
21 CFR Part 866
Microbiology Devices; Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management, To Be Renamed Quantitative Cytomegalovirus Nucleic Acid Tests for Transplant Patient Management; Federal Register Vol. 85, Issue
PRORULE
2020-20716
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2020-11-17
Docket No. FDA-2016-N-2880
4164-01-P
2020-20716
Proposed amendment; proposed order; request for comments.
The Food and Drug Administration (FDA or the Agency) is proposing to reclassify cytomegalovirus (CMV) deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management, a postamendments class III device (product code PAB) into class II (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name ``quantitative cytomegalovirus (CMV) nucleic acid tests for transplant patient management'' to identify these devices along with the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness for the device. 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 manufacturers of 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 November 17, 2020. Please see section XII 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, 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
Microbiology Devices:
Reclassification of Cytomegalovirus Deoxyribonucleic Acid Quantitative Assay Devices Intended for Transplant Patient Management, To Be Renamed Quantitative Cytomegalovirus Nucleic Acid Tests for Transplant Patient Management,
Silke.Schlottmann@fda.hhs.gov
https://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/MicrobiologyDevicesPanel/UCM531275.pdf
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM514771
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 85, no. 182
Office of the Federal Register, National Archives and Records Administration
2020-09-18
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https://www.govinfo.gov/app/details/FR-2020-09-18
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https://www.govinfo.gov/content/pkg/FR-2020-09-18/xml/FR-2020-09-18.xml
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