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2020-01-22
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Medical Devices; Radiology Devices; Classification of the Radiological Computer Aided Triage and Notification Software
Rules and Regulations
D09002ee1bdb614aa
D09002ee1bdb61a12
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or we) is classifying the radiological computer aided triage and notification software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiological computer aided triage and notification software's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
85 FR 3543
https://www.govinfo.gov/app/details/FR-2020-01-22/2020-00496
2020-00496
fr22ja20-3
4164-01-P
Docket No. FDA-2019-N-5589
https://www.govinfo.gov/app/details/FR-2020-01-22/2020-00496
https://www.govinfo.gov/content/pkg/FR-2020-01-22/html/2020-00496.htm
https://www.govinfo.gov/content/pkg/FR-2020-01-22/pdf/2020-00496.pdf
Medical Devices
Radiation Protection
X-Rays
3 p.
3543
3545
85 FR 3543
Code of Federal Regulations
Title 21 Part 892
21 CFR Part 892
Medical Devices; Radiology Devices; Classification of the Radiological Computer Aided Triage and Notification Software; Federal Register Vol. 85, Issue
RULE
2020-00496
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2020-01-22
Docket No. FDA-2019-N-5589
4164-01-P
2020-00496
Final amendment; final order.
The Food and Drug Administration (FDA or we) is classifying the radiological computer aided triage and notification software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the radiological computer aided triage and notification software's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
This order is effective January 22, 2020. The classification was applicable on February 13, 2018.
Ryan Lubert, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 3574, Silver Spring, MD 20993-0002, 240-402-6357, ryan.lubert@fda.hhs.gov.
Medical Devices
Radiation Protection
X-Rays
Medical Devices; Radiology Devices:
Classification of the Radiological Computer Aided Triage and Notification Software,
ryan.lubert@fda.hhs.gov
Federal Register
Vol. 85, no. 14
Office of the Federal Register, National Archives and Records Administration
2020-01-22
continuing
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281 p.
Table of Contents:
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GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2020-01-22
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0042-1219
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https://www.govinfo.gov/app/details/FR-2020-01-22
https://www.govinfo.gov/content/pkg/FR-2020-01-22/pdf/FR-2020-01-22.pdf
https://www.govinfo.gov/content/pkg/FR-2020-01-22/xml/FR-2020-01-22.xml
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DGPO
2020-01-22
2023-04-28
FR-2020-01-22
machine generated
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FR-2020-01-22
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