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 2018-10-26 article Proposed Rules D09002ee1c7ed445a D09002ee1c7ed4539 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) is proposing to implement regulations regarding internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to conform to the applicable provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA) and the 21st Century Cures Act (Cures Act). FDA is taking this action to codify the procedures and timeframes for supervisory review of significant decisions pertaining to devices within CDRH. FDA is also proposing regulations to provide new procedural requirements for requesting internal agency supervisory review within CDRH of other types of decisions made by CDRH not addressed in FDASIA and the Cures Act. This action is also part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve its public health mission and fulfill statutory obligations. 83 FR 2388 https://www.govinfo.gov/app/details/FR-2018-01-17/2018-00646 2018-00646 fr17ja18-16 RIN 0910-AH37 4164-01-P Docket No. FDA-2016-N-2378 https://www.govinfo.gov/app/details/FR-2018-01-17/2018-00646 https://www.govinfo.gov/content/pkg/FR-2018-01-17/html/2018-00646.htm https://www.govinfo.gov/content/pkg/FR-2018-01-17/pdf/2018-00646.pdf Administrative Practice and Procedure News Media Medical Devices Ophthalmic Goods and Services Packaging and Containers Reporting and Recordkeeping Requirements 6 p. 2388 2393 83 FR 2388 Title 21 Part 10 21 CFR Part 10 Title 21 Part 800 21 CFR Part 800 RIN 0910-AH37 Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by the Center for Devices and Radiological Health; Federal Register Vol. 83, Issue PRORULE 2018-00646 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2018-04-17 Docket No. FDA-2016-N-2378 4164-01-P 2018-00646 Proposed rule.

The Food and Drug Administration (FDA) is proposing to implement regulations regarding internal agency supervisory review of certain decisions related to devices regulated by the Center for Devices and Radiological Health (CDRH) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to conform to the applicable provisions in the Food and Drug Administration Safety and Innovation Act (FDASIA) and the 21st Century Cures Act (Cures Act). FDA is taking this action to codify the procedures and timeframes for supervisory review of significant decisions pertaining to devices within CDRH. FDA is also proposing regulations to provide new procedural requirements for requesting internal agency supervisory review within CDRH of other types of decisions made by CDRH not addressed in FDASIA and the Cures Act. This action is also part of FDA's implementation of Executive Orders (EOs) 13771 and 13777. Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal, replacement, or modification that will result in meaningful burden reduction, while allowing the Agency to achieve its public health mission and fulfill statutory obligations.

Submit either electronic or written comments by April 17, 2018. See section V of this document for the proposed effective date of a final rule that may issue based on this proposal. Adaeze Teme, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5574, Silver Spring, MD 20993-0002, 240-402-0768; or the Ombudsman for the Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4282, Silver Springs, MD 20993-0002, 301-796-5669, or CDRHOmbudsman@fda.hhs.gov. Administrative Practice and Procedure News Media Medical Devices Ophthalmic Goods and Services Packaging and Containers Reporting and Recordkeeping Requirements Internal Agency Review of Decisions; Requests for Supervisory Review of Certain Decisions Made by Center for Devices and Radiological Health , CDRHOmbudsman@fda.hhs.gov http://heinonline.org/HOL/PDFsearchable?handle=hein.fedreg/040171&collection=fedreg&section=0&id=179&print=1&sectioncount=1&ext=.pdf&nocover= http://heinonline.org/HOL/PDFsearchable?handle=hein.fedreg/042016&collection=fedreg&section=0&id=250&print=1&sectioncount=1&ext=.pdf&nocover= http://heinonline.org/HOL/PrintRequest?collection=fedreg&nocover=&handle=hein.fedreg%2F043216&id=186&section=&skipstep=1&fromid=186&toid=238&format=PDFsearchable&submitx=Print%2FDownload&submit1=Print%2FDownload+Custom+Range http://heinonline.org/HOL/PrintRequest?collection=fedreg&nocover=&handle=hein.fedreg%2F044073&id=258&section=&skipstep=1&fromid=258&toid=376&format=PDFsearchable&submitx=Print%2FDownload&submit1=Print%2FDownload+Custom+Range http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM284670.pdf http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm313794.pdf http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM352254.pdf http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm393978.pdf http://www.regulations.gov https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf https://www.regulations.gov Vol. 83, no. 11 Office of the Federal Register, National Archives and Records Administration 2018-01-17 continuing daily deposited born digital 204 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2018-01-17 P0b002ee19d7f91fb 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr17ja18 https://www.govinfo.gov/app/details/FR-2018-01-17 https://www.govinfo.gov/content/pkg/FR-2018-01-17/pdf/FR-2018-01-17.pdf https://www.govinfo.gov/content/pkg/FR-2018-01-17/xml/FR-2018-01-17.xml fdlp 2329 2524 DGPO 2018-10-26 2024-06-01 FR-2018-01-17 machine generated eng FR FR-2018-01-17 83 11