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ADA 1081-2015
- FDA's Unique Device Identifiction (UDI) Program for Dental Devices and Biologics Regulated as Medical Devices - Technical Report
- standard by American Dental Association, 07/10/2015
- Publisher: ADA
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The Food and Drug Administration (FDA) has issued a rule to establish a system to adequately identify devices through distribution. This rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement. The labeler must submit product information concerning devices to FDA's Global Unique Device Identification Database (GUDID), unless subject to an exception or alternative. The system established by this rule requires the label and device package of each medical device to include a UDI and requires that each UDI be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI will be required to be directly marked on the device itself, if the device is intended to be used more than once and intended to be reprocessed before each use
Once it was recognized that this rule was going to take effect, practitioners needed to have an understanding of this rule and what it will entail as it is required to go into practice, from a clinician side. The manufacture chain and responsibilities have been clearly identified by the FDA, but the clinical use has not; and thus that was determined to be the main focus of this paper. This paper covers the UDI Rule (78 FR 58786) and device marking regulations in 21 CFR 801.45. It does not cover the regulations for medical device tracking found in 21 CFR 821. There is no tracking requirement within the UDI rule.
Once it was recognized that this rule was going to take effect, practitioners needed to have an understanding of this rule and what it will entail as it is required to go into practice, from a clinician side. The manufacture chain and responsibilities have been clearly identified by the FDA, but the clinical use has not; and thus that was determined to be the main focus of this paper. This paper covers the UDI Rule (78 FR 58786) and device marking regulations in 21 CFR 801.45. It does not cover the regulations for medical device tracking found in 21 CFR 821. There is no tracking requirement within the UDI rule.
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