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

Sam Lazzara

Trusted Information Resource
#1
I have drafted this high level task list intended for medical device labelers who want to implement FDA requirements for Unique Device Identification. Did I miss anything?

1. Determine FDA 21 CFR requirements applicable to your devices.

2. Perform gap analysis between FDA requirements and current quality system.

3. Create Quality Plan for UDI implementation.

4. Select FDA-accredited issuing agency.

5. Select and procure label printing system (printer and software). If needed also select and procure device marking system.

6. Design and procure package label stock(s) with primary printing.

7. Choose barcode style to be used for UDI.

8. Develop secondary/production label printing ?artwork? using software. Same goes for device markings if required.

9. Select and procure barcode verification system.

10. Update quality system documents to support UDI implementation.

11. Verify/validate UDI application process (protocol, execution, report).

12. Confirm implementation readiness per Quality Plan, enter UDI information into FDA Global UDI Database (GUDID), and GO LIVE!

I continue to update this page with new UDI related info when I see it.
 
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M

mr.mike

#3
Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

Thanks Sam. ...but a few comments & questions:

1. What is the relationship between UDI and FDA 21 CFR? I can't find any reference to UDI requirements in the 21 CFR.
EDIT: My bad, I see now that the final ruling, http://www.gpo.gov/fdsys/pkg/FR-2013-09-24/pdf/2013-23059.pdf, does clearly state the changes to the FDA 21 CFR sections. ...that being said, the dates seem to be off. For example, changes to section 801 listed as effective Dec.23,2013, but the changes still haven't been made. Presumably this is just the FDA being late to update their documents on schedule?

2. Presently, the only accredited agencies listed on the FDA's UDI advice page are GS1 US and HIBCC. I would presume that any GS1 branch will suffice (as companies outside the US cannot register with GS1 US)? I've made an inquiry to the FDA UDI Help Desk regarding this...

3. What do you mean by a "barcode verification system"?
- Do you mean simply a check that a barcode meets the requirements of the chosen format? This is built-in to most barcode generating software, no?
- Or by this do you mean actually checking the barcode against GUDID and GS1/HIBCC databases?
 
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Sam Lazzara

Trusted Information Resource
#4
Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

Dear mr.mike,

1. Go here to get latest CFR updates that impacted these 21 CFR Parts - 16, 801, 803, 806, 810, 814, 820, 821, 822, 830. Part 830 is the only brand new part.

2. GS1 is a global organization with offices around the world. For my clients who do not have more than 100 REF (Catalog) numbers, I have recommended the annual fee of $750 (first year) and $150 annual thereafter, which will get them a 10-digit company prefix that we will integrate into the "device identifier" portion of our UDI number. That will leave room for a 2-digit item code good for up to 100 items (REF numbers). These are used to create GTIN-14 device identifiers and GS1-128 linear bar codes.
Here is a link to the GS1 application form I have used.
Important point - this is a membership application for a company prefix, not a membership application to join GS1 as a voting member - that costs more.

3. Bar code verification means checking to ensure it meets the ISO/ANSI standards. This is more than just a scanner. It provides an A B C D F grade based on the criteria in ISO 15416 and ANSI X3.182. Here is a link an example of a verifier that will do the job.
 
M

mr.mike

#5
Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

Hi Sam,

Thanks for the eCFR link, I guess this is the official online source?
...I find it odd that these aren't updated on the actual FDA website though.

In terms of GS1, being from Canada, we has to apply for a company code from the local GS1 Canada office. My concern that GS1ca is not listed on the FDA website as an accredited agency. Only GS1 US is.
Like I say, I've put in an inquiry to the FDA UDI help, and will update this thread once I hear a response.

Without a copy of the ISO 15416 standard, might I ask in general what type of factors need verifying? Is it mostly related to the print quality and size?
 

Sam Lazzara

Trusted Information Resource
#6
Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

mr. mike,

I have found the eCFRs to be the mostly timely source for revised regulations. You will typically find that the CFRs published here are not very current.

In addition to asking the FDA Helpdesk I think you should query GS1 Canada directly to get their take on your question.

To access an English preview of EN ISO/IEC 15416, including the entire table of contents, go here. You can purchase a single-user copy for under 15 Euros.

Bar code verifiers test print quality. The quality measurements should be per ISO/IEC 15416 for linear symbols and ISO/IEC 15415 for 2D symbols.
For linear bar codes, ISO/IEC 15416 specifies that the minimum symbol grade shall be 1.5/10/660 where:
• minimum print quality grade at point of production = 1.5 (C)
• measurement aperture = 0.254 mm = 0.010 inches (that is what the "10" above signifies)
• inspection wavelength = 660 nanometers +/- 10 nanometers
 
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S

samtam

#7
Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

Thanks Sam. This is very helpful.

Would you have any suggestions on how UDI can be incorporated by Medical Device companies in improving complaint handling and Post marketing surveillance?

Regards
Samir
 
M

mr.mike

#8
Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

Hi Samir,

My own feeling is that additional benefits offered by UDIs in terms of Complaint Handling and Post-Market Surveillance would really depend on the nature of the product.

Personally, I don't see much added value for us, as all the information contained in the UDIs are already clearly marked on our current labels...

For regional regulatory agencies, however, it may provide an easier system for tracking, as all UDI device identifiers will be registered in databases, and required when reporting adverse incidents.

MM
 

Sam Lazzara

Trusted Information Resource
#9
Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

I agree with MM.

For complaint handling and post marketing activities, manufacturers are already using the REF (Catalog Number), Lot Number, Use By Date, etc. that is codified into the UDI.

Having UDIs on the device packaging or device itself (for reusable devices) might facilitate the ability of healthcare facilities to identify devices subject to a field action, but I doubt it.

Be on the lookout for reg agencies (such as FDA) who may require UDI info to be included in reports you send to the agencies (such as Part 803 MDRs and Part 806 Correction/Removal Reports for FDA).
 
M

mr.mike

#10
Re: 12 Steps to FDA UDI (Unique Device Identification) Compliance (2013)

I've confirmed with the FDA UDI help desk and with GS1 Canada:

Any regional GS1 office is an FDA accredited issuer for UDIs.

The FDA's now updated their website to list just "GS1" instead of "GS1 US".
 
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