Source: https://www.enlabel.com/compliance/udi?qt-tabs_udi=3
Timestamp: 2019-04-21 13:14:18+00:00

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As part of the UDI system, the FDA is also creating the Global Unique Device Identification Database (GUDID) which will include a standard set of basic identifying elements for each device with a UDI. Most of this information will be made available to the public so that users of a medical device can easily look up information about the device. The UDI does not indicate, and the database will not contain, any information about who uses a device, including personal privacy information.
The FDA has issued Global Unique Device Identification Database (GUDID) - Guidance for Industry and FDA Staff (pdf)to give labelers an overview of the GUDID. This guidance is designed to help labelers prepare to submit information to the GUDID by describing key GUDID concepts such as accounts, user roles, the device identifier record life cycle, package configurations, and the GUDID data attributes and descriptions.
Enhance analysis of devices on the market by providing a standard and clear way to document device use in electronic health records, clinical information systems, claim data sources and registries. A more robust post market surveillance system can also be leveraged to support premarket approval or clearance of new devices and new uses of currently marketed devices.
Manage UDI standards with minimal impact to your overall manufacturing and quality processes.
Sharply enforced and ever-evolving UDI regulations shed light on existing gaps, workarounds and inefficiencies within labeling processes, across an enterprise.
As a result of uncovering such setbacks, UDI regulations should serve as a catalyst, and business justification, to improve or simplify operational processes.
Dynamically include production specific and product specific details in the identifier (lot + item).
Use flexible bar coding standards (GS1, EAN, RFID, 2D and 1D) with minimal impact to operations.
Deploy trace & track capability throughout the entire supply chain, from received goods to distribution to the point of use.
Prepare for 2016 and beyond with minimal changes to your current manufacturing process.
Achieve zero defects in your labeling, documentation and packaging processes.
The table below outlines key compliance dates in the UDI final rule.
The labels and packages of Class III medical devices, and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI. § 801.20.
Dates on the labels of these devices must be formatted as required by § 801.18. Data for these devices must be submitted to the GUDID database. § 830.300.
A 1-year extension of this compliance date may be requested under § 801.55; such a request must be submitted no later than June 23, 2014.
The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI. § 801.20.
A device that is a life-supporting, or a life-sustaining device that is required to be labeled with a UDI must a 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. § 801.45.
Data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database. §830.300.
A Class II device that is required to be labeled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
Class I devices, and devices that have not been classified into Class I, Class II, or ClassIII that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.
Compliance dates for all other provisions of the final rule. Except for the provisions listed above, FDA requires full compliance with the final rule as of the effective date that applies to the provision.
An issuing agency is an FDA-accredited organization that operates a system for assignment of UDIs according to the final rule. The final rule permits multiple issuing agencies and provides a process through which an applicant would seek FDA accreditation as an issuing agency.
Applicants seeking initial FDA accreditation as an issuing agency shall notify the FDA via email at udi@fda.hhs.gov.

References: § 801
 § 801
 § 830
 § 801
 § 801
 § 801
 §830
 § 801
 § 801