GUDID Archives

LexisNexis Reed Tech and 1WorldSync Webinar Recap: Leveraging UDI and GDSN

Global Data Synchronization Network, Medical Devices, Unique Device Identification

On Tuesday, October 15, 2024, Reed Tech and 1WorldSync hosted a highly informative webinar led by Gary Saner, Senior Regulatory Principal at Reed Tech, and Scott Brown, Senior Director of Global Data Strategy at 1WorldSync. The webinar focused on how their continued alliance helps companies navigate Unique Device Identification (UDI) management and utilize the Global Data Synchronization Network (GDSN) to meet regulatory compliance requirements.

Understanding FDA UDI Compliance Requirements for Medical Device Manufacturers

Medical Devices, Unique Device Identification

What are the potential consequences for medical device manufacturers not following through with product data submissions and labeling requirements? In a recent inspection, violations were identified regarding a manufacturer’s Unique Device Identification (UDI)...

Med Devices Missing in GUDID and Obsolete GMDN Codes in GUDID

Medical Devices, Unique Device Identification

The U.S. Food and Drug Administration (FDA) recently initiated two initiatives to improve the completeness and quality of the Global Unique Device Identification Database (GUDID).

Class I UDI Inventory Exception: What You Need to Know about FDA Compliance

Medical Devices, Unique Device Identification

In 2013, the FDA granted a UDI exception for 3 years after the corresponding Compliance Date for finished medical devices manufactured and labeled without Unique Device Identification (UDI) as of the Compliance Date, commonly referred to as the 3-Year Inventory UDI Exception or the ‘Final Rule.’ Such devices meeting the criteria could be commercially distributed for 3 years after the corresponding Compliance Date without complying with UDI requirements. At the end of the 3-year period, any undistributed inventory would need to be reprocessed to comply with current UDI requirements, i.e., UDI Label and GUDID reporting.

HL7 Structured Product Labeling and the True Cost of the Free FDA Web Interface

Medical Devices, Unique Device Identification

Did you know? The FDA Class I deadline enforcement is occurring on December 8, 2022. Many in the medical device industry make plans to use the free FDA Web Interface based on the assumption that they don’t have enough products to warrant the use of Structured Product...

Why You Need a UDI Specialist

Medical Devices, Unique Device Identification

Did you know there are multiple health authorities around the globe with current or future requirements for medical device product data specifically for Unique Device Identification (UDI) standards? The list continues to grow (US FDA, EU EUDAMED, South Korea MFDS,...

UDI and 21 CFR Part 11

Medical Devices, Unique Device Identification

Medical device manufacturers working to comply with the FDA’s Unique Device Identification mandate have more than one set of regulations to keep in mind. Fortunately, some of the regulations have been in place for some time and will be at least somewhat familiar to...

GS1 UDI – How GDSN, GTIN, & GS1 Affect UDI

Medical Devices, Unique Device Identification

Simplify global medical device data with UDI, GTIN, GLN, and GDSN standards for regulatory compliance and supply chain efficiency.

UDI: How do I assign Device Identifiers?

Medical Devices, Unique Device Identification

As you work on implementing UDI, you may be wondering how to assign the Device Identifier (DI) portion of the UDI to your products and how to make sense of the different levels of DIs in a single GUDID record. These are questions we receive from industry members all...

FDA GUDID UDI compliance: Accuracy required

Medical Devices, Unique Device Identification

Unique Device Identification (UDI) product data submissions require not just that your system for sending data to the FDA’s Global Unique Device Identification Database (GUDID) be in place and functioning smoothly. It requires that the data you send through that...

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Recent Blogs

LexisNexis Reed Tech and 1WorldSync Webinar Recap: Leveraging UDI and GDSN

Understanding FDA UDI Compliance Requirements for Medical Device Manufacturers

Med Devices Missing in GUDID and Obsolete GMDN Codes in GUDID

Class I UDI Inventory Exception: What You Need to Know about FDA Compliance

HL7 Structured Product Labeling and the True Cost of the Free FDA Web Interface

Why You Need a UDI Specialist

UDI and 21 CFR Part 11

GS1 UDI – How GDSN, GTIN, & GS1 Affect UDI

UDI: How do I assign Device Identifiers?

FDA GUDID UDI compliance: Accuracy required

Knowledge Center