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United States
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Regulatory Information
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2018-11-02
article
Medical Devices; Gastroenterology-Urology Devices; Classification of the Fluid Jet System for Prostate Tissue Removal
Rules and Regulations
D09002ee1bdb8d06a
D09002ee1bdb8d0c1
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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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or we) is classifying the fluid jet system for prostate tissue removal 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 fluid jet system for prostate tissue removal'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.
83 FR 27895
https://www.govinfo.gov/app/details/FR-2018-06-15/2018-12829
2018-12829
fr15jn18-4
4164-01-P
Docket No. FDA-2018-N-1894
https://www.govinfo.gov/app/details/FR-2018-06-15/2018-12829
https://www.govinfo.gov/content/pkg/FR-2018-06-15/html/2018-12829.htm
https://www.govinfo.gov/content/pkg/FR-2018-06-15/pdf/2018-12829.pdf
Medical Devices
4 p.
27895
27898
83 FR 27895
Code of Federal Regulations
Title 21 Part 876
21 CFR Part 876
Medical Devices; Gastroenterology-Urology Devices; Classification of the Fluid Jet System for Prostate Tissue Removal; Federal Register Vol. 83, Issue
RULE
2018-12829
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2018-06-15
Docket No. FDA-2018-N-1894
4164-01-P
2018-12829
Final order.
The Food and Drug Administration (FDA or we) is classifying the fluid jet system for prostate tissue removal 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 fluid jet system for prostate tissue removal'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 June 15, 2018. The classification was applicable on December 21, 2017.
Jessica Cades, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. G246, Silver Spring, MD, 20993-0002, 240-402-3900, Jessica.Cades@fda.hhs.gov.
Medical Devices
Medical Devices:
Gastroenterology-Urology Devices; Classification of the Fluid Jet System for Prostate Tissue Removal
,
Jessica.Cades@fda.hhs.gov
Federal Register
Vol. 83, no. 116
Office of the Federal Register, National Archives and Records Administration
2018-06-15
continuing
daily
deposited
born digital
269 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2018-06-15
P0b002ee19d998919
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr15jn18
https://www.govinfo.gov/app/details/FR-2018-06-15
https://www.govinfo.gov/content/pkg/FR-2018-06-15/pdf/FR-2018-06-15.pdf
https://www.govinfo.gov/content/pkg/FR-2018-06-15/xml/FR-2018-06-15.xml
fdlp
27889
28150
DGPO
2018-11-02
2023-04-28
FR-2018-06-15
machine generated
eng
FR
FR-2018-06-15
83
116