Category 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!

Sponsored: The Many Faces Of The FDA

MultiFacesWhy 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.

Right from the beginning you had an agency with at least three faces:  foods, drugs and cosmetics.  Continue reading Sponsored: The Many Faces Of The FDA

FDA Considering A Delay Of A Small Part Of The UDI Rule

1622-468x60_AprilFor 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.

Way back in around 1970 the FDA created a numbering system for drugs and one for devices.  The one for drugs Continue reading FDA Considering A Delay Of A Small Part Of The UDI Rule

Sponsored: The Best Source Of UDI Guidance

1573-125x125_June_aniEach year on September 24 the FDA Unique Device Identification (UDI) final rule applies to another set of medical devices in the United States.  That is the anniversary of the publication of the UDI final rule in 2013 (see “InBrief: FDA Publishes Final UDI Rule”).  This year on that date, the set of devices that must comply with the rule includes implantable, life-supporting and life-sustaining devices for the first time.  Manufacturers of those devices should be in the process of making the changes necessary to comply.  And so, it is time again for the best source of Continue reading Sponsored: The Best Source Of UDI Guidance

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

FDA Posts Small Entity Compliance Guide For UDI and GUDID

CDRH.CBER.logosYesterday the FDA posted a new document on their website with the title, “Unique Device Identification System: Small Entity Compliance Guide, Guidance for Industry and Food and Drug Administration Staff”.  The document is 23 pages long and it includes an explanation—in what the FDA calls “plain language”—of the FDA’s Unique Device Identification (UDI) system and the Global Unique Device Identification Database (GUDID).  It is aimed at small businesses, but it is a good read for anyone who wants an overview of the regulation.  The guidance contains non-binding recommendations for companies who must meet the UDI final rule, including makers of class III medical devices, which must comply by September 24 of this year.

The document was a requirement under Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996.  That act requires the FDA to Continue reading FDA Posts Small Entity Compliance Guide For UDI and GUDID

Requesting an Extension/Exception to the U.S. FDA UDI Rules

iStock_000011089235SmallerAre you behind in your preparations for the September 24, 2014 deadline for Unique Device Identification on class III medical devices (see “UDI Deadline For Class III Medical Devices Quickly Approaching”)?  Do you need to apply for an 1-year extension of the compliance date for a class III medical device or a device licensed under the Public Health Service Act?  Do you need to file an exception from or alternative to the requirement for the label of a device to bear a unique device identifier (§ 801.20) or other UDI requirement under 21 CFR 801 Subpart B (Labeling Requirements for Unique Device Identification) for a specified device or a specified type of device?  Do you need to continue using an existing National Health Related Item Code (NHRIC) or National Drug Code (NDC) Labeler Code that was assigned to you by the FDA in the past (see “UDI And The Approaching End Of The NDC”)?

If you answered “yes”, or, “Uh…I think so”, to any of the questions above, then Continue reading Requesting an Extension/Exception to the U.S. FDA UDI Rules