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2010-09-24
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Medical Devices; Reclassification and Exemption From Premarket Notification for Certain Classified Devices
Rules and Regulations
D09002ee1be0532ff
D09002ee1be053310
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) is reclassifying 111 generic types of class II devices into class I based on new information respecting such devices. FDA is also exempting the 111 generic types of devices, and 11 already classified generic types of class I devices, from the requirement of premarket notification, with limitations. For the exempted devices, FDA has determined that manufacturers' submissions of premarket notifications are unnecessary for the protection of the public health and that the agency's review of such submissions will not advance its public health mission. The exemptions allow the agency to make better use of its resources and thus better serve the public. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking is part of the President's and Vice President's Reinventing Government effort.
61 FR 1117
https://www.govinfo.gov/app/details/FR-1996-01-16/96-418
96-418
fr16ja96-5
RIN 0910-AA65
4160-01-F
Docket No. 95N-0139
https://www.govinfo.gov/app/details/FR-1996-01-16/96-418
https://www.govinfo.gov/content/pkg/FR-1996-01-16/html/96-418.htm
https://www.govinfo.gov/content/pkg/FR-1996-01-16/pdf/96-418.pdf
10 p.
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21 CFR Part 862
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21 CFR Part 866
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21 CFR Part 868
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21 CFR Part 870
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21 CFR Part 872
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21 CFR Part 874
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21 CFR Part 876
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21 CFR Part 878
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21 CFR Part 880
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21 CFR Part 882
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21 CFR Part 884
Regulation Identification Number 0910-AA65
RIN 0910-AA65
Medical Devices; Reclassification and Exemption From Premarket Notification for Certain Classified Devices; Federal Register Vol. 61, Issue
RULE
96-418
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
1996-02-15
Docket No. 95N-0139
4160-01-F
96-418
Final rule.
The Food and Drug Administration (FDA) is reclassifying 111 generic types of class II devices into class I based on new information respecting such devices. FDA is also exempting the 111 generic types of devices, and 11 already classified generic types of class I devices, from the requirement of premarket notification, with limitations. For the exempted devices, FDA has determined that manufacturers' submissions of premarket notifications are unnecessary for the protection of the public health and that the agency's review of such submissions will not advance its public health mission. The exemptions allow the agency to make better use of its resources and thus better serve the public. These devices will remain subject to current good manufacturing practice (CGMP) regulations and other general controls. This rulemaking is part of the President's and Vice President's Reinventing Government effort.
Effective February 15, 1996. Beginning on February 15, 1996, all device manufacturers who have 510(k) submissions pending FDA review for devices falling within a generic category which is subject to this rule, will receive a letter stating that the device is exempt from the premarket notification requirements of the act.
Melpomeni K. Jeffries, Center for Devices and Radiological Health (HFZ-404), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 301-594- 2186.
Federal Register
Vol. 61, no. 10
Office of the Federal Register, National Archives and Records Administration
1996-01-16
continuing
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48 p.
Table of Contents:
AE 2.7:
GS 4.107:
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https://www.govinfo.gov/app/details/FR-1996-01-16
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0364-1406
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000582072
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https://www.govinfo.gov/app/details/FR-1996-01-16
https://www.govinfo.gov/content/pkg/FR-1996-01-16/pdf/FR-1996-01-16.pdf
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