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2018-11-03
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Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff; Availability
Notices
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United States
Department of Health and Human Services
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United States Government Agency or Subagency
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Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff.'' This guidance describes FDA's intention with respect to the enforcement of unique device identification requirements for class I and unclassified devices, other than implantable, life-sustaining, or life-supporting (I/LS/LS) devices. FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements for these devices before September 24, 2020. In addition, FDA does not intend to enforce direct mark requirements for these devices before September 24, 2022. This guidance also describes FDA's direct mark compliance policy for class III, LS/ LS, and class II devices that are nonsterile, manufactured and labeled prior to their applicable direct mark compliance date, and remain in inventory, as well as for class I and unclassified devices that are nonsterile, manufactured and labeled prior to September 24, 2022, and remain in inventory. FDA does not intend to enforce the direct mark requirements for these devices when the device's unique device identifier (UDI) can be derived from other information directly marked on the device. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
83 FR 55372
https://www.govinfo.gov/app/details/FR-2018-11-05/2018-24177
2018-24177
fr05no18-63
4164-01-P
Docket No. FDA-2017-D-6841
https://www.govinfo.gov/app/details/FR-2018-11-05/2018-24177
https://www.govinfo.gov/content/pkg/FR-2018-11-05/html/2018-24177.htm
https://www.govinfo.gov/content/pkg/FR-2018-11-05/pdf/2018-24177.pdf
3 p.
55372
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83 FR 55372
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff; Availability; Federal Register Vol. 83, Issue
NOTICE
2018-24177
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2017-D-6841
4164-01-P
2018-24177
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance entitled ``Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking; Immediately in Effect Guidance for Industry and Food and Drug Administration Staff.'' This guidance describes FDA's intention with respect to the enforcement of unique device identification requirements for class I and unclassified devices, other than implantable, life-sustaining, or life-supporting (I/LS/LS) devices. FDA does not intend to enforce standard date formatting, labeling, and Global Unique Device Identification Database (GUDID) data submission requirements for these devices before September 24, 2020. In addition, FDA does not intend to enforce direct mark requirements for these devices before September 24, 2022. This guidance also describes FDA's direct mark compliance policy for class III, LS/ LS, and class II devices that are nonsterile, manufactured and labeled prior to their applicable direct mark compliance date, and remain in inventory, as well as for class I and unclassified devices that are nonsterile, manufactured and labeled prior to September 24, 2022, and remain in inventory. FDA does not intend to enforce the direct mark requirements for these devices when the device's unique device identifier (UDI) can be derived from other information directly marked on the device. The guidance document is immediately in effect, but it remains subject to comment in accordance with the Agency's good guidance practices.
The announcement of the guidance is published in the Federal Register on November 5, 2018.
For Center for Devices and Radiological Health-regulated devices: Christina Savisaar, UDI Regulatory Policy Support, 10903 New Hampshire Ave., Bldg. 66, Rm. 3319, 301-796-5995, email: GUDIDSupport@fda.hhs.gov.
Guidance:
Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking
,
CDRH-Guidance@fda.hhs.gov
GUDIDSupport@fda.hhs.gov
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 83, no. 214
Office of the Federal Register, National Archives and Records Administration
2018-11-05
continuing
daily
deposited
born digital
216 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2018-11-05
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0042-1219
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000582072
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https://www.govinfo.gov/app/details/FR-2018-11-05
https://www.govinfo.gov/content/pkg/FR-2018-11-05/pdf/FR-2018-11-05.pdf
https://www.govinfo.gov/content/pkg/FR-2018-11-05/xml/FR-2018-11-05.xml
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2018-11-03
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FR-2018-11-05
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FR-2018-11-05
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