FDA Provides On-Demand UDI Training
For me, the highlight of the FDA Weekly Digest Bulletin distributed Sept. 29, 2013, was the announcement of a module that has been added to the CDRH Learn Course list: "Unique Device Identification (UDI) System -- The Final Regulation."
Curiosity caused me to follow this link to find the CDRH Learn Course List and click on the new module at the bottom of the page. That's where I found the educational items listed below.
First, I read the informative transcript. Then I viewed the slides. Finally, I listened to the comforting voice of the presenter, Jay Crowley. This FDA senior adviser for patient safety explains his topic very clearly with example labels and plenty of guidance.
In the early part of his presentation, I was pleased to have three concepts confirmed. First, Crowley tells us that the final rule for the configuration of the date in UDI changes to the YYYYMMDD format, as in ISO 8601. He emphasises that year/month is inadequate; the day must always be included.
Second, he explains what a UDI is:
[It's] a code, alpha-numeric or numeric code, on a device label, its packaging, or on the device itself, and it is represented in both plain text and machine-readable format. Importantly, there are two parts to the UDI - the Device Identifier, which is specific to a particular version or model of the device, and the Production Identifiers, which are those control mechanisms that are currently used on a label or device itself.
He also explains:
There are typically one or more control mechanisms that are used, a lot or batch numbers, serial numbers, manufacturing dates, and expiration dates. The UDI rule does not require any particular Production Identifiers to be used, rather whatever Production Identifiers are currently on that device or on the label of that device are the ones that would be used in the UDI.
It will be a relief for many MDMs when they note that Crowley advises, "We are not requiring devices that are currently lot controlled to have serial numbers."
Third, he confirms:
[The FDA has been] have been working with three organizations over the last 5 or 6 years and do expect each of these organizations to submit requests to be accredited issuing agencies. They are GS1, HIBCC, and ICCBBA. A manufacturer will choose to work with one of more of these issuing agencies and will develop a UDI according to the standards of those organizations.
This news is a welcome indication that those MGMs with bar coding, printed to the standards of one of these agencies, will not have to change to one of the other agencies. This will surely be a relief to many.
There is much, much more information in Crowley's presentation. I have only highlighted three areas that affect packaging engineers whose remit includes label control and printing. I advocate the viewing of Jay Crowley's presentation by all who are involved in the labelling of medical devices or the control and storage of labelling information.
Rolande Hall, FIMMM Pkg Prof