Tag Archives: UDI

European Medical Device and In Vitro Diagnostic Medical Device Regulations Conference

Author Karen Fleshman

Once again I’ve asked Karen Fleshman, co-founder and COO of Haskins Advisory Group, to step in and cover the recent EU MDR and IVDR Conference that focused on Unique Device Identification (UDI).  I’ll return after the holidays with more coverage of pharma serialization.  Thanks Karen! –Dirk.

On December 4 – 6, 2017, the European Medical Device (MDR) and In Vitro Diagnostic Medical Device (IVDR) Regulations Conference was held in Orlando, FL. The conference was designed to educate, support, and assist US based medical device manufacturers in gaining critical insight on the requirements of the European Union (EU)’s Unique Device Identification (UDI) compliance program. Continue reading European Medical Device and In Vitro Diagnostic Medical Device Regulations Conference

Sponsored: RxTrace to Sponsor the 2017 UDI Conference – June 7 & 8 in Baltimore, MD!

One of my favorite conferences each year is the annual Unique Device Identification (UDI) Conference put on by the Clarion Group on behalf of the Food and Drug Administration (FDA).  I am happy to sponsor the event each year, and I try to attend when I can.  

As an educational authority on UDI, the 9th annual UDI Conference will Continue reading Sponsored: RxTrace to Sponsor the 2017 UDI Conference – June 7 & 8 in Baltimore, MD!

NDC Nearing Its End, Afflicted by ‘Identifier Failure’

business-executive-and-his-energy-level-concept-vector-cartoon-i-507717540_4911x3472Heart Failure is a human condition that is characterized by several easily identifiable symptoms, including fatigue, difficulty breathing and in its later stages, gurgled breathing.  My mother and my mother-in-law both suffered from heart failure during their decline.  Analogous to heart failure in humans is a condition of an identifier system that is near the end of its useful life that we can call “identifier failure”.  At the end of November, a new FDA final guidance called “Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs” went into effect.  Buried deep within this 200+ page document is the official announcement that signaled the National Drug Code (NDC) identifier system is now afflicted with this end-stage condition.  The NDC won’t last long now, and there is no longer any excuse for inaction.  The need for a replacement is now urgent. Continue reading NDC Nearing Its End, Afflicted by ‘Identifier Failure’

Product Identification And National Registration Codes

iStock_000090544423_smallerThere is a long-running tug-of-war going on between GS1 and national governments around the world over how exactly to identify medical products, whether devices or pharmaceuticals.  National governments regulate those products to maximize the health of their citizens and so they take a natural interest in how they are identified.  They want to eliminate all ambiguity between products within their market.  They need to be able to tightly grant market authorization, revoke it and oversee recalls when warranted.  To do that effectively, they need a way of clearly and concisely referencing a given product.  That same way of referencing the product should also be used for patient education and for healthcare professional prescribing.  Bad things happen when mistakes are made in the identification of healthcare products.

GS1 offers a global standard way of identifying Continue reading Product Identification And National Registration Codes

An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon

Dear FriendDear FDA,

Thanks for inviting me to your DSCSA Pilot Party this week.  I look forward to visiting you at your Silver Spring home so we can catch up on what’s been happing in our lives recently.  I’m glad you are thinking more about the Drug Supply Chain Security Act (DSCSA) lately.  I am too.

In fact, I’ve been thinking about how nice it would be if you would fix the broken National Drug Code (NDC) as part of the implementation of the DSCSA.  It’s really not very hard to do.  You already laid out and tested the path that needs to be followed when you implemented the Unique Device Identification (UDI) numbering system for medical devices a few years ago.

Remember how happy that made me?  Remember, I called it “revolutionary” (see “FDA Proposed UDI: A Revolution In Number Assignment”), and it was!  But before I get to how you could do it for pharmaceuticals, let me explain why you should do it as clearly as I can. Continue reading An Open Letter To The FDA, RE: Please Fix The National Drug Code Soon

The DSCSA, the NDC, Inventory Management, GS1 GTINs…and Turkeys

Thanksgiving is my favorite holiday!
Giving thanks!  It is my favorite holiday and I have a lot to be thankful for.

Until the Drug Supply Chain Security Act (DSCSA) was passed as part of the Drug Quality and Security Act (DQSA) last year (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), companies could use whatever code they wanted to refer to the prescription drug products in supply chain operations and for their own inventory management.  Some probably chose the 10-digit National Drug Code (NDC), some probably chose the 11-digit reimbursement code that is based on the 10-digit NDC, and some probably chose to use a 12- or 14-digit GS1 Global Trade Item Number (GTIN) as a reference code for their inventory data.  But now that the DSCSA mandates the use of the 10-digit NDC when exchanging transaction data on January 1, companies using the other codes that are based on the NDC might need to Continue reading The DSCSA, the NDC, Inventory Management, GS1 GTINs…and Turkeys

Everything You Need To Know About UDI In One Neat Package

UDI Conference 2014 bannerManufacturers of class III medical devices are (hopefully) breathing a sigh of relief today after the recent scurry of activity leading up to yesterday’s deadline for meeting the FDA’s Unique Device Identifier (UDI) regulation.  Now they can relax, right?  Well, odds are, most of them also make class II devices, and maybe even some that are “life supporting and/or life sustaining” devices as well, which means the march toward the next UDI deadlines has to start all over again.

Fortunately, the experience gained by those who faced this first deadline can help guide those who need to meet the next one(s).  Device distributors and hospitals will Continue reading Everything You Need To Know About UDI In One Neat Package

Is Your Drug Exempt From The Federal Drug Supply Chain Security Act? Revisited

Exempt signI am working this week, but I know this is a popular time for vacations, especially for those who do not have children in school.  I typically write my Monday essays over the weekend, but because it was a holiday weekend and my wife and I did some leisure traveling, I decided to re-post a popular essay from earlier this year:  “Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?“.

I wrote this essay to help companies, large and small, figure out whether or not their products might be exempt from the DSCSA.  In it, I provide a kind of a formula that you can use to determine if a given product is exempt or not.  At least it’s a series of questions or statements that you can ask yourself about your product.  So without further ado,

IS YOUR DRUG EXEMPT FROM THE FEDERAL DRUG SUPPLY CHAIN SECURITY ACT?

Ever since the Drug Quality and Security Act (DQSA) was signed into law last November Continue reading Is Your Drug Exempt From The Federal Drug Supply Chain Security Act? Revisited