Find out what your organization needs to do in order to comply with FDA regulations.

1. 1WorldSync Support for
Compliance with FDA
UDI Regulation
In order to comply with FDA regulations, is your organization:
·· Determining the scope of products impacted?
·· Sourcing your data from multiple locations, formats and systems, controlled
by different functions?
·· Concerned the data you provide to the FDA is complete and accurate?
·· Seeking to understand GS1 Standards?
1WorldSync provides a seamless and proven process for your company to collect,
store, distribute, and manage your product information with customers, trading
partners, and to populate in the FDA’s Global UDI Database (GUDID).
1WorldSync has the solution and services to assist your organization in compliance
with this FDA regulation. Our solutions and industry experts will help you create a
sustainable process to publish compliant product information to the GUDID, and
create a single version of the truth for your product information.
Our industry experts will help you:
·· PEFORM a readiness assessment for your Class III, II and Class I medical devices
·· IDENTIFY areas of impact within your company
·· CREATE improved long-term data management processes to meet regulatory
and consumer information demands
·· ADOPT GS1 Standards and comply with business requirements put forth by
the Healthcare Transformation Group
CONNECTING TRUSTED PRODUCT DATA EVERYWHERE
FDA REGULATION:
UNIQUE DEVICE
IDENTIFIER FOR
MEDICAL DEVICES
The United States Food and Drug Administration (FDA) released a regulation
on September 24, 2013, requiring medical device product information to be
provided to the FDA in order to more easily and accurately identify and trace
medical devices. Compliance for the regulation is broken into four time-frames
based on the FDA’s normal 3 level device classification plus a fourth category
based on refinement/separation of Class II devices. The new regulation requires
most medical devices to be marked and labeled with a unique device identifier
(UDI) and then entered into the FDA’s Global Unique Device Identification
Database (GUDID) with a set of FDA-specified attributes.

2. About 1WorldSync
1WorldSync manages the world’s product data so that companies can share trusted
product information with each other and with consumers, driving business and
convenience for everyone. As the industry leader in global product data management
and data pool solutions certified for the Global Data Standardization Network (GDSN),
1WorldSync can meet the needs of any trading partner in any industry. 1WorldSync
is part of GS1®, the developer of the global standards for identifying, capturing, and
sharing product information. For more information please visit 1worldsync.com.
CONNECTING TRUSTED PRODUCT DATA EVERYWHERE
1WorldSync
1009 Lenox Drive, Suite 202, Lawrenceville, NJ 08648 USA
T +1 866 280 4013 F +1 609 620 1200 E info@1worldsync.com
1worldsync.com© 1WorldSync 2014
Connect With Us:
Contact Us
For more information on how
1WorldSync can help with FDA
regulation, please contact:
Nicholas Manzo
Sr. Director Industry Development
T +1 312.810.42494
E nmanzo@1worldsync.com
SEPTEMBER 24, 2014 | CLASS III
Labels and packages of all Class III medical
devices and devices listed under the Public
Health Service Act must have an UDI. Data
for these devices must be submitted to
GUDID.
SEPTEMBER 25, 2015
Labels and packages of implantable,
life-supporting, and life-sustaining devices
must have an UDI. Data for these devices
must be submitted to GUDID.
SEPTEMBER 24, 2016 | CLASS II
Labels and packages of Class II medical
devices must have an UDI. Data for these
devices must be submitted to GUDID.
SEPTEMBER 24, 2018 | CLASS I
Labels and packaged of Class I medical
devices and devices that have not been
classified into Class I, Class II or Class III
must have an UDI. Data for these devices
must be submitted to GUDID.
With the 1WorldSync healthcare offering, we provide a simple, but
comprehensive solution to capture, manage and share your product
information. 1WorldSync is actively empowering manufacturers to:
·· PREPARE product information to be compliant to FDA UDI regulations
·· CAPTURE and aggregate data across multiple countries and markets to ensure
compliance with medical device regulations throughout the global supply chain,
including International Medical Device Regulators Forum (IMDRF)
·· MANAGE product information from multiple entry points to ensure complete and
accurate information
·· DISTRIBUTE product information using a timely, manageable and
auditable methodology.
The 1WorldSync UDI Connector Solution key features and
benefits include:
·· Direct integration with FDA UDI interface, so your organization does not need to
build a dedicated pipe
·· Combined UDI device information sharing with a platform for any device related
information. Access to 23,000 trading partners for distribution via GS1 GDSN®
network, or any trading partner not on the GDSN, via an any-to-any link
·· Reduced cost to address UDI
·· Solve for multiple regulatory needs, such as medical device regulations throughout
the global supply chain, including IMDRF