12 Steps to FDA UDI (Unique Device Identification) Compliance (2013 - 2015)

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

I agree and there are clear benefits from the perspective of regulatory agencies. Also I have seen that FDA's 3500A form requires UDI #.

Excuse my ignorance ..but is GTIN (provided by GS1) same as UDI?
Regards
Samir

12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

UDI = DI + PI
GTIN = DI only

DI = Device Identifier
PI = Production Identifier

GTIN = Global Trade Identification Number (based on GS1 as issuing agency)

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

Hi Samir,

As you know, UDI is made up of:
- Device Identifier (DI): Identifies company and device
- Production Identifier (PI): Identifies other device-specific info (batch, serial, dates..etc.)

GS1 will give you a "Company Prefix"

You will then use this to construct GTIN numbers for each of your products:
GTIN = Company Prefix (assigned by GS1) + Item Reference (selected by you)

As you can see, the GTIN will now fulfill the DI requirement of UDI.

The final UDI, however will also contain GS1 "application identifiers" (AIs) to give the PI portion of the UDI.

Here's a (simplified) breakdown:

UDI
= DI + PI
= GTIN + GS1 AIs
= GS1 Company Prefix + Item Reference + GS1 AIs

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

Sam,

Sorry I am coming late to this thread, but you're really taken the information from the FDA's new UDI rule and brought it down to where most people can understand what they need to do.

Thank YOU

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

Sam:
My thanks as well for the informative posts. I am working on a report for management regarding the requirements for using UDI's. We currently use the 3d barcodes to confirm the order is complete and for traceability however we have over 50,000 part numbers! With this amount, way more than the 100 you used in your example,do you have any suggestions how we can proceed?
Once again, Thanks!

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

I agree ... Sam has done a great job in simplifying the complex UDI requirements

I have made this thread sticky so that it remains at top of list thread listings !

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

Can you please clarify what you mean by 3D bar codes?
Who is your issuing agency? GS1 or HIBCC?
Are your REF (Catalog) Numbers full numeric or alpha-numeric?

50,000 items, wow! You need a 6-digit item reference if you are using GS1.

Please see attached current GS1 Company Prefix Fee Schedule.
For your situation it will cost you $10,500 the first year and $2,100 per year thereafter. That fee will allow you to have up to 100,000 items. I predict that you will spend less money if you use HIBCC instead of GS1 - see below.

GS1 also has an informative Excel calculator (attached) that will help you to determine fee and understand things better.

HIBCC's registration fee to obtain a Labeler Identification Code (LIC), analogous to GS1's Company Prefix, is a one-time fee based upon a progressive fee‐schedule that is tied the labelers gross annual sales in its immediate prior fiscal year. See the current HIBCC fee information in the attached screen shot I took.

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

Here is an article called FDA UDI (DI+PI) FAQ that I put together for an upcoming ASQ newsletter.

I would appreciate comments, error corrections, questions, etc.

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

On page 1, you have mentioned GS1 and HIBCC are the only choices at this time; you could add ICCBBA which was added last month.

Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

A nice article -- thanks for sharing it!

Sam Lazzara said:

Here is an article called FDA UDI (DI+PI) FAQ that I put together for an upcoming ASQ newsletter.

I would appreciate comments, error corrections, questions, etc.

Click to expand...

A minor item -- you mention the World Series being limited to the USA -- while your general point is valid the fact is that Canada also plays. Perhaps stating that the series is limited to North America...?

A general question -- would it be worth it to consider adding a section touching on the particulars of UDI for software-only medical devices?