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2019-12-30
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Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices
Rules and Regulations
D09002ee1a44c43cd
D09002ee1a44c44b6
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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United States Government Agency or Subagency
The Food and Drug Administration (FDA, Agency, or we) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA published the lists of final determinations in accordance with procedures established by the 21st Century Cures Act (Cures Act). Although each classification regulation for each such type of device shall be deemed amended to incorporate such exemption, we are publishing this final order to amend the codified language for each listed class I and class II device's classification regulation to reflect the final determinations. FDA's action decreases regulatory burden on the medical device industry and eliminates private costs and expenditures required to comply with certain Federal regulations.
84 FR 71794
https://www.govinfo.gov/app/details/FR-2019-12-30/2019-27394
2019-27394
fr30de19-13
4164-01-P
Docket Nos. FDA-2017-N-1129 and FDA-2017-N-1610
https://www.govinfo.gov/app/details/FR-2019-12-30/2019-27394
https://www.govinfo.gov/content/pkg/FR-2019-12-30/html/2019-27394.htm
https://www.govinfo.gov/content/pkg/FR-2019-12-30/pdf/2019-27394.pdf
Medical Devices
Blood
Packaging and Containers
Biologics
Laboratories
Ophthalmic Goods and Services
Radiation Protection
X-Rays
26 p.
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84 FR 71794
Code of Federal Regulations
Title 21 Part 862
21 CFR Part 862
Code of Federal Regulations
Title 21 Part 864
21 CFR Part 864
Code of Federal Regulations
Title 21 Part 866
21 CFR Part 866
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Title 21 Part 868
21 CFR Part 868
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Title 21 Part 870
21 CFR Part 870
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Title 21 Part 872
21 CFR Part 872
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21 CFR Part 874
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Title 21 Part 876
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
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21 CFR Part 886
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Title 21 Part 888
21 CFR Part 888
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Title 21 Part 890
21 CFR Part 890
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Title 21 Part 892
21 CFR Part 892
Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices; Federal Register Vol. 84, Issue
RULE
2019-27394
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-12-30
Docket Nos. FDA-2017-N-1129 and FDA-2017-N-1610
4164-01-P
2019-27394
Final amendment; final order.
The Food and Drug Administration (FDA, Agency, or we) identified a list of class I devices and class II devices that are now exempt from premarket notification requirements, subject to certain limitations. FDA published the lists of final determinations in accordance with procedures established by the 21st Century Cures Act (Cures Act). Although each classification regulation for each such type of device shall be deemed amended to incorporate such exemption, we are publishing this final order to amend the codified language for each listed class I and class II device's classification regulation to reflect the final determinations. FDA's action decreases regulatory burden on the medical device industry and eliminates private costs and expenditures required to comply with certain Federal regulations.
This order is effective December 30, 2019.
Karen Fikes, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5502, Silver Spring, MD 20993, 301-796- 9603, email: karen.fikes@fda.hhs.gov.
Medical Devices
Blood
Packaging and Containers
Biologics
Laboratories
Ophthalmic Goods and Services
Radiation Protection
X-Rays
Medical Devices:
Exemptions From Premarket Notification for Class I and Class II Devices,
karen.fikes@fda.hhs.gov
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/procedures-class-ii-device-exemptions-premarket-notification-guidance-industry-and-cdrh-staff
Federal Register
Vol. 84, no. 249
Office of the Federal Register, National Archives and Records Administration
2019-12-30
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Table of Contents:
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https://www.govinfo.gov/content/pkg/FR-2019-12-30/pdf/FR-2019-12-30.pdf
https://www.govinfo.gov/content/pkg/FR-2019-12-30/xml/FR-2019-12-30.xml
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