Home » All Life Sciences Resources » UDI: Best Practices in Data Management, Barcoding and Direct Marking
UDI experts Gary Saner (Reed Tech) and Michael Barron (Domino) discuss best practices for medical device labelers seeking to comply with the FDA's Unique Device Identification mandate.
FDA now accepting REMS in SPL format
Submission of REMS in SPL will help to clarify and standardize REMS content across the industry, making FDA...
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UK NHS eProcurement: The What, Who, Why and When
eProcurement is a requirement for any organization doing business with an NHS care provider. For most device companies operating in the U.K., NHS is by far the largest customer in that market.
Why the FDA Extended the Class I UDI Deadline (and What the Delay Means for You)
FDA’s Class I extension is about ensuring GUDID data quality and submission accuracy, not about giving industry time to work on other projects.
Structured Product Labeling, Eh? Health Canada’s SPL Pilot
Health Canada is working with volunteer manufacturers and sponsors, as well as technology vendors, to test the application of the HL7 SPL standard to the content of drug product monographs.
FDA Insight: UDI Data Quality
Why Data Accuracy in Drug Listings is Essential
This month, FDA issued a warning letter to an OTC drug labeler for failing to provide complete and accurate information in the metadata sections of two drug listing files.
GDSN for NHS eProcurement and Buyer Data Requests Webinar Reed Tech 1WorldSync
Despite Extension, 2017 UDI Deadline Still Holds for Certain Contact Lenses
FDA delayed the UDI deadline for soft contact lenses to a future undetermined date but the September 24, 2017 deadline for rigid, gas-permeable contact lenses remains unchanged.
Reed Tech Introduces GDSN Capabilities in Collaboration with 1WorldSync™
The Reed Tech Life Sciences Team is pleased to announce that we are now offering a full-service solution to allow medical device organizations to share product data through the GDSN.
Zoom In: A Closer Look at Device Safety Data
There is a staggering amount of medical device safety data available from U.S. government sources. Where can we find it? What can it tell us?
In the Spotlight: Medical Device Safety and Quality Events
UDI Update: New FDA GUDID Technical Documents Released
FDA sent an email to its list of UDI GUDID email subscribers with updated GUDID Data Elements Reference Table and GUDID HL7 SPL Implementation Files.
Reed Tech® Introduces Reed Tech Navigator™ for Medical Devices
Navigator is a new analytics and research solution that makes it easy to analyze and compare the safety and quality of tens of thousands of medical device products.
Drug Product Annual Reporting Periods
GDUFA Self-Identification: What Generic Companies Need to Know
Reed Tech subject matter expert Jon Nolan talks GDUFA and Self-Identification during a webinar March 8, 2017.
UDI & GDSN Webinar - Making the most of your GUDID Data
GDSN expert Peter Alvarez of GS1 and UDI expert Gary Saner of Reed Tech discuss how medical device labelers can utilize the Global Data Synchronization Network (GDSN) to capitalize on their investment
GDUFA and Self-Identification: What’s changing? (And What’s Not?)
GDUFA requires sites engaged in certain generic drug activities to self-identify annually prior to paying a user fee set by the agency.
Reed Tech Announces Agreement with GDSN Data Pool Solutions Provider 1WorldSync
This agreement will allow Reed Tech customers to access the Global Data Synchronization Network (GDSN) and provide 1WorldSync customers with expanded options for managing their regulatory data.
FDA’s Electronic Drug Listing Requirements for Manufacturers
National Drug Code (NDC) Assignment Guide eBook
GS1, GTIN, GDSN--What do they have to do with UDI?