United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2017_register executive 2018-11-14 article Notices D09002ee1c7f149fa D09002ee1c7f14ab0 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA or Agency) is announcing a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA's final determination with respect to the list of class II devices proposed in a March 14, 2017, Federal Register document. The exemptions in this notice will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. 82 FR 31976 https://www.govinfo.gov/app/details/FR-2017-07-11/2017-14453 2017-14453 fr11jy17-73 4164-01-P Docket No. FDA-2017-N-1129 https://www.govinfo.gov/app/details/FR-2017-07-11/2017-14453 https://www.govinfo.gov/content/pkg/FR-2017-07-11/html/2017-14453.htm https://www.govinfo.gov/content/pkg/FR-2017-07-11/pdf/2017-14453.pdf 27 p. 31976 32002 82 FR 31976 Medical Devices; Exemptions From Premarket Notification: Class II Devices; Federal Register Vol. 82, Issue NOTICE 2017-14453 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2017-N-1129 4164-01-P 2017-14453 Notice.

The Food and Drug Administration (FDA or Agency) is announcing a list of class II devices that the Agency has determined based on established factors to no longer require premarket notification to provide reasonable assurance of safety and effectiveness, subject to certain limitations. FDA is publishing this notice of that determination in accordance with procedures established by the 21st Century Cures Act. This notice represents FDA's final determination with respect to the list of class II devices proposed in a March 14, 2017, Federal Register document. The exemptions in this notice will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations.

Bryce Bennett, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5244, Silver Spring, MD 20993, email: Gregory.Bennett@fda.hhs.gov. Medical Devices: Exemptions from Premarket Notification; Class II Devices , Gregory.Bennett@fda.hhs.gov http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf https://www.regulations.gov Vol. 82, no. 131 Office of the Federal Register, National Archives and Records Administration 2017-07-11 continuing daily deposited born digital 245 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2017-07-11 P0b002ee19dc03e06 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr11jy17 https://www.govinfo.gov/app/details/FR-2017-07-11 https://www.govinfo.gov/content/pkg/FR-2017-07-11/pdf/FR-2017-07-11.pdf https://www.govinfo.gov/content/pkg/FR-2017-07-11/xml/FR-2017-07-11.xml fdlp 31887 32121 DGPO 2018-11-14 2024-06-01 FR-2017-07-11 machine generated eng FR FR-2017-07-11 82 131