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2018-12-07
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Medical Device De Novo Classification Process
Proposed Rules
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D09002ee1bdb7def0
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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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) proposes to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The proposed requirements establish procedures and criteria related to requests for De Novo classification (``De Novo request''). These requirements are intended to ensure the most appropriate classification of devices consistent with the protection of the public health and the statutory scheme for device regulation, as well as to limit the unnecessary expenditure of FDA and industry resources that may occur if devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness are subject to premarket approval. The proposed rule, if finalized, would implement the De Novo classification process under the FD&C Act, as enacted by the Food and Drug Administration Modernization Act of 1997 and modified by the Food and Drug Administration Safety and Innovation Act and the 21st Century Cures Act.
83 FR 63127
https://www.govinfo.gov/app/details/FR-2018-12-07/2018-26378
2018-26378
fr07de18-16
RIN 0910-AH53
4164-01-P
Docket No. FDA-2018-N-0236
https://www.govinfo.gov/app/details/FR-2018-12-07/2018-26378
https://www.govinfo.gov/content/pkg/FR-2018-12-07/html/2018-26378.htm
https://www.govinfo.gov/content/pkg/FR-2018-12-07/pdf/2018-26378.pdf
Administrative Practice and Procedure
Medical Devices
20 p.
63127
63146
83 FR 63127
Code of Federal Regulations
Title 21 Part 860
21 CFR Part 860
Regulation Identification Number 0910-AH53
RIN 0910-AH53
Medical Device De Novo Classification Process; Federal Register Vol. 83, Issue
PRORULE
2018-26378
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2019-03-07
Docket No. FDA-2018-N-0236
4164-01-P
2018-26378
Proposed rule.
The Food and Drug Administration (FDA) proposes to establish requirements for the medical device De Novo classification process under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The proposed requirements establish procedures and criteria related to requests for De Novo classification (``De Novo request''). These requirements are intended to ensure the most appropriate classification of devices consistent with the protection of the public health and the statutory scheme for device regulation, as well as to limit the unnecessary expenditure of FDA and industry resources that may occur if devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness are subject to premarket approval. The proposed rule, if finalized, would implement the De Novo classification process under the FD&C Act, as enacted by the Food and Drug Administration Modernization Act of 1997 and modified by the Food and Drug Administration Safety and Innovation Act and the 21st Century Cures Act.
Submit either electronic or written comments on the proposed rule by March 7, 2019. Submit comments on information collection issues under the Paperwork Reduction Act of 1995 by January 7, 2019.
Sergio de del Castillo, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993, 301- 796- 6419.
Administrative Practice and Procedure
Medical Devices
Medical Device De Novo Classification Process
,
oira_submission@omb.eop.gov
https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm
https://www.fda.gov/BiologicsBloodVaccines/default.htm
https://www.fda.gov/cdrhsubmissionaddress
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM080199.pdf
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm348890.pdf
https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM507278.pdf
https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm126396.pdf
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm080197.pdf
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm313794.pdf
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm446680.pdf
https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm517504.pdf
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 83, no. 235
Office of the Federal Register, National Archives and Records Administration
2018-12-07
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2018-12-07
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https://www.govinfo.gov/content/pkg/FR-2018-12-07/pdf/FR-2018-12-07.pdf
https://www.govinfo.gov/content/pkg/FR-2018-12-07/xml/FR-2018-12-07.xml
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