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UDI Rule for Medical Devices Finally Issued

Cheryl Clark, for HealthLeaders Media, September 23, 2013

The timetable for UDI implementation:

  • Sept. 24, 2014 — Labels and packages of Class III medical devices and devices licensed under the Public Health Service Act must bear a UDI. Dates on labels must be formatted and data submitted to GUDID.
  • Sept. 24, 2015 — Labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. And these devices must bear UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
  • Sept. 24, 2016 — Class III devices required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
  • Sept. 24, 2018 — Class II devices that are required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. The labels and packages of Class I medical devices and devices that have not been classified into Class I, II, or III must bear a UDI. And data for Class I devices and devices not classified that are required to be labeled with a UDI must be submitted to the GUDID database.

Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists.
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