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 2018_register executive 2018-12-15 article Rules and Regulations D09002ee1c7dd87d5 D09002ee1c7dd89b7 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, the Agency, or we) is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is also making additional changes unrelated to the FDASIA requirements, to update its regulations governing the classification and reclassification of medical devices. FDA is taking this action to codify the procedures and criteria that apply to the classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation. 83 FR 64443 https://www.govinfo.gov/app/details/FR-2018-12-17/2018-27015 2018-27015 fr17de18-6 RIN 0910-AH75 4164-01-P Docket No. FDA‐2013-N-1529 https://www.govinfo.gov/app/details/FR-2018-12-17/2018-27015 https://www.govinfo.gov/content/pkg/FR-2018-12-17/html/2018-27015.htm https://www.govinfo.gov/content/pkg/FR-2018-12-17/pdf/2018-27015.pdf Administrative Practice and Procedure Medical Devices 16 p. 64443 64458 83 FR 64443 Title 21 Part 860 21 CFR Part 860 RIN 0910-AH75 Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures; Federal Register Vol. 83, Issue RULE 2018-27015 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2019-03-18 Docket No. FDA‐2013-N-1529 4164-01-P 2018-27015 Final rule.

The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend its regulations governing classification and reclassification of medical devices to conform to the applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). FDA is also making additional changes unrelated to the FDASIA requirements, to update its regulations governing the classification and reclassification of medical devices. FDA is taking this action to codify the procedures and criteria that apply to the classification and reclassification of medical devices and to provide for classification of devices in the lowest regulatory class consistent with the public health and the statutory scheme for device regulation.

This rule is effective March 18, 2019. For information concerning the final rule as it relates to devices regulated by the Center for Devices and Radiological Health (CDRH): Ana Loloei, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave, Bldg. 66, Rm. 5452, Silver Spring, MD 20993-0002. Administrative Practice and Procedure Medical Devices Medical Device Classification Procedures: Incorporating Food and Drug Administration Safety and Innovation Act Procedures , https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm240318.htm https://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/ucm378724.htm https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm https://www.fda.gov/downloads/RegulatoryInformation/Guidances/ucm236144.pdf https://www.fda.gov/MedicalDevices/ucm285317.htm https://www.regulations.gov Vol. 83, no. 241 Office of the Federal Register, National Archives and Records Administration 2018-12-17 continuing daily deposited born digital 306 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2018-12-17 P0b002ee19e295468 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr17de18 https://www.govinfo.gov/app/details/FR-2018-12-17 https://www.govinfo.gov/content/pkg/FR-2018-12-17/pdf/FR-2018-12-17.pdf https://www.govinfo.gov/content/pkg/FR-2018-12-17/xml/FR-2018-12-17.xml fdlp 64433 64728 DGPO 2018-12-15 2024-05-31 FR-2018-12-17 machine generated eng FR FR-2018-12-17 83 241