Title 21 published on 2015-04-01 .
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
2015-11-23; vol. 80 # 225 - Monday, November 23, 2015 80 FR 72899 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostate Lesion Documentation System
GPO FDSys: XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective November 23, 2015. The classification was applicable on April 27, 2012. 21 CFR Part 876 Summary The Food and Drug Administration (FDA) is classifying the prostate lesion documentation system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the prostate lesion documentation system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
2015-06-23; vol. 80 # 120 - Tuesday, June 23, 2015 80 FR 35842 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation; Republication
GPO FDSys: XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order; republication. This order is effective June 23, 2015. The classification was applicable on March 20, 2015. 21 CFR Part 876 Summary The Food and Drug Administration (FDA) is republishing in its entirety a final order entitled “Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation” that published in the Federal Register on May 28, 2015 (80 FR 30353). FDA is republishing to correct an inadvertent omission of information. FDA is classifying the vibrator for climax control of premature ejaculation into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the classification of the vibrator for climax control of premature ejaculation. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
2015-06-01; vol. 80 # 104 - Monday, June 1, 2015 80 FR 30931 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Rectal Control System
GPO FDSys: XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective June 1, 2015. The classification was applicable on February 12, 2015. 21 CFR Part 876 Summary The Food and Drug Administration (FDA) is classifying the rectal control system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the rectal control system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
2015-05-28; vol. 80 # 102 - Thursday, May 28, 2015 80 FR 30353 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation
GPO FDSys: XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective May 28, 2015. The classification was applicable on March 20, 2015. 21 CFR Part 876 Summary The Food and Drug Administration (FDA) is classifying the vibrator for climax control of premature ejaculation into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the classification of the vibrator for climax control of premature ejaculation. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
2015-04-06; vol. 80 # 65 - Monday, April 6, 2015 80 FR 18307 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Urethral Insert With Pump for Bladder Drainage
GPO FDSys: XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective April 6, 2015. The classification was applicable on October 14, 2014. 21 CFR Part 876 Summary The Food and Drug Administration (FDA) is classifying the urethral insert with pump for bladder drainage into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the urethral insert with pump for bladder drainage's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.
This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office] .
It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.
United States Code U.S. Code: Title 21 - FOOD AND DRUGS
Title 21 published on 2015-04-01
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 876 after this date.
2015-11-23; vol. 80 # 225 - Monday, November 23, 2015 80 FR 72899 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostate Lesion Documentation System
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective November 23, 2015. The classification was applicable on April 27, 2012. 21 CFR Part 876 Summary The Food and Drug Administration (FDA) is classifying the prostate lesion documentation system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the prostate lesion documentation system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
2015-06-23; vol. 80 # 120 - Tuesday, June 23, 2015 80 FR 35842 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation; Republication
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order; republication. This order is effective June 23, 2015. The classification was applicable on March 20, 2015. 21 CFR Part 876 Summary The Food and Drug Administration (FDA) is republishing in its entirety a final order entitled “Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation” that published in the Federal Register on May 28, 2015 (80 FR 30353). FDA is republishing to correct an inadvertent omission of information. FDA is classifying the vibrator for climax control of premature ejaculation into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the classification of the vibrator for climax control of premature ejaculation. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
2015-06-01; vol. 80 # 104 - Monday, June 1, 2015 80 FR 30931 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Rectal Control System
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective June 1, 2015. The classification was applicable on February 12, 2015. 21 CFR Part 876 Summary The Food and Drug Administration (FDA) is classifying the rectal control system into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the rectal control system's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
2015-05-28; vol. 80 # 102 - Thursday, May 28, 2015 80 FR 30353 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Vibrator for Climax Control of Premature Ejaculation
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective May 28, 2015. The classification was applicable on March 20, 2015. 21 CFR Part 876 Summary The Food and Drug Administration (FDA) is classifying the vibrator for climax control of premature ejaculation into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the classification of the vibrator for climax control of premature ejaculation. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
2015-04-06; vol. 80 # 65 - Monday, April 6, 2015 80 FR 18307 - Medical Devices; Gastroenterology-Urology Devices; Classification of the Urethral Insert With Pump for Bladder Drainage
GPO FDSys XML | Text Additional Documents DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration Final order. This order is effective April 6, 2015. The classification was applicable on October 14, 2014. 21 CFR Part 876 Summary The Food and Drug Administration (FDA) is classifying the urethral insert with pump for bladder drainage into class II (special controls). The special controls that will apply to the device are identified in this order and will be part of the codified language for the urethral insert with pump for bladder drainage's classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.
