US Food and Drug Administration Unique Device Identifier Rule: Perioperative Basics

Author:

Karas Claire

Publisher

Wiley

Subject

Medical–Surgical Nursing

Reference6 articles.

1. Study Group 1 of the Global Harmonization Task Force. Definition of the terms ‘medical device’ and ‘in vitro diagnostic (IVD) medical device.’ http://www.imdrf.org/docs/ghtf/final/sg1/technical-docs/ghtf-sg1-n071-2012-definition-of-terms-120516.pdf. Accessed February 11, 2016.

2. Unique Device Identification (UDI) implementation. Brookings Institution. http://www.brookings.edu/about/centers/health/projects/development-and-use-of-medical-devices/udi. Accessed November 4, 2015.

3. Drozda JP Jr, Helmering P, Moore V, Smith TR. Advancement of innovative methodologies and medical device specific infrastructure for evidence-based regulatory science and public health surveillance: final report. US Food and Drug Administration. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/BenefitsofaUDIsystem/UCM416128.pdf. Accessed November 4, 2015.

4. Study Group 1 of the Global Harmonization Task Force. Definition of the terms ‘medical device’ and ‘in vitro diagnostic (IVD) medical device.’ GS1. http://www.gs1.org/docs/healthcare/ghtf-sg1-n071-2012-definition-of-terms-120516.pdf. Published May 16, 2012. Accessed November 4, 2015.

5. Galoozis C. UDI is here to stay—how will it impact providers? Medtronic. http://sharinghealthcaresolutions.covidien.com/udi-is-here-to-stay—how-will-it-impact-providers-. Published July 23, 2014. Accessed December 8, 2015.

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