This event has been rescheduled to April 12-13, 2021.
Calling all medical device manufacturers, distributors, GPO’s, Providers, and healthcare industry stakeholders to make plans now to be in Baltimore in ???! The 12th annual UDI Conference continues to be the platform for you to stay informed about the latest developments in UDI implementation, enabling technology, regulatory updates, Provider momentum, and Global expansion.
GS1 makes modifications and additions to their General Specifications every year—sometimes even twice a year. The latest is version 19 and was published in January 2019. The “GenSpecs” contain the full detailed definitions of every GS1 “key” and every GS1 barcode. While it doesn’t contain the definitions of every GS1 standard, it is the catch-all specification for their traditional core—mostly barcode related—standards. This is where GS1’s keys are defined, included the Global Trade Item Number (GTIN, Application Identifier, or AI = 01), Global Location Number (GLN), Serial Shipping Container Code (SSCC, AI = 00), Global Returnable Asset Identifier (GRAI, AI = 8003) and all the others. Last year (GenSpecs version 18) GS1 introduced their latest key, the Global Model Number (GMN, AI = 8013). It’s an important addition, particularly for healthcare. Let me explain.
Why is there such a wide gap between the actions of the UDI face of the FDA and the DSCSA face?
The U.S. Food and Drug Administration (FDA) is an agency of the U.S. government that falls under the Department of Health and Human Services, which is under the leadership of the current Presidential Administration through a cabinet seat. But it is also a concept, and the concept has been conceived, modified, adjusted, influenced and expanded—especially expanded—by many thousands of members of Congress that have served from 1906 to 2016. It started as a nearly powerless monitoring agency in 1906 with the passage of the Federal Food and Drugs Act. But in the aftermath of a number of widely-reported incidents of harm and deaths caused by cosmetics and medicines, the Congress passed the original Food, Drug and Cosmetics Act (FD&C) in 1938 and President Franklin D. Roosevelt signed it into law.
For the second time this week, the FDA posted something related to the things I pay the most attention to. Earlier this week it was about the DSCSA. This time it was a draft guidance for comment on a proposed delay in enforcement of a small part of the Unique Device Identification (UDI) final rule. I’ve seen a lot of mentions around the internet about this new FDA posting but none of them really explain it very well (including the FDA). I’d like to take a stab.
Medical device manufacturers have a choice of standards to use when identifying their products for the U.S. market. The FDA’s Unique Device Identification (UDI) rule allows them to select from any identification standards organization (referred to as a “number issuing” agency) that is accredited by the Agency for that purpose. So far, three organizations have been FDA-accredited: HIBCC, ICCBBA and GS1.
Both the California ePedigree law and the potential federal pedigree law that currently exists within the womb that is H.R. 3204 contain an exemption for drug-device combination products. This is an expanding category of products so this exemption is worthy of a closer look.
Last month, Eli Lilly posted a video about their serialization initiative on YouTube. It features Grant Lindman, Manager of Lilly’s Global Anti-Counterfeiting Operations, and David Colombo, Commercial Implementation Leader of Lilly’s Global Serialization Program talking about their global serialization program. It is worth a listen. Continue reading Eli Lilly: “Serialization Needs Standardization”→
…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.