Regulatory Open Forum

The current UDI Final Rule states the following PI information as variable:

(a) The Lot or Batch within which a device was manufactured

(b) The Serial Number

(c) The Expiration Date

(d) the Manufacture Date

(e) stuff for an HCT/P device not applicable to us

Currently, we tack the following information on an internal bar code:

1) Serial Number, which includes the Model Number and Work order number (essentially our Lot information). 

2) BOM Assembly Revision 

To merge this data into the UDI format, may we pick which information goes into which field?  For instance, if we want to say the BOM Assembly Revision is the "Batch" information, and put it in field (a), can we do that?  Then the Work Order plus 3 digits would be considered the "Serial Number" and would go in field (b)?

Thanks!

By the way you wrote the question, I want to be sure of some issues. Please forgive me if I’ve misunderstood.

When the UDI says the production identifiers (PIs) are variable, they mean they are optional. The use of PIs can vary from product to product. This is in contrast to the device identifier which is mandatory.

The first question is whether or not you use any of the PIs on the device label currently. The best approach is to look at the label specification in your DMR and the primary label you put into recent DHRs. (Of course they will match, but the primary label will have the specific information, not just a placeholder as is typical in the DMR version.

The information in your internal bar code doesn’t count. The UDI rule is concerned only with the information you provide to the customer on the label. (You will also load GUDID with information that will become public.)

Let’s assume you have chosen to use at least on PI. The information is presented in two ways: a) easily readable plain text and b) automatic identification and data capture (AIDC).

The easily readable plain text format is controlled by FDA. If it includes a date, then be sure to implement the new date format.

The AIDC format is controlled by the specifications you will receive from the Issuing Agency you choose; there are three choices. Let’s assume you pick a linear bar code. It must conform to the specifications in terms of length, characters allowed, order of characters, format, etc. Chances are, your internal bar code does not conform.

In summary, the PIs are optional and the UDI rule does not require to any that you don’t already use. The AIDC format is specified by your issuing agency, so their soecs become part of your QMS.

Thanks Dan. But perhaps I wasn't clear with my question.  I understand that we may pick and choose what PIs we have.  My question was more about definition of "serial number", "lot", and "batch".  To my knowledge, the FDA has not defined these terms.  Therefore, it is up to the manufacturer to define them how we want.  If we want to call the BOM assembly revision the "batch", we can do that right, and put that revision letter in the "batch" field of the UDI?

Sorry for the confusion!

The current UDI Final Rule states the following PI information as variable:

(a) The Lot or Batch within which a device was manufactured

(b) The Serial Number

(c) The Expiration Date

(d) the Manufacture Date

(e) stuff for an HCT/P device not applicable to us

Currently, we tack the following information on an internal bar code:

1) Serial Number, which includes the Model Number and Work order number (essentially our Lot information). 

2) BOM Assembly Revision 

To merge this data into the UDI format, may we pick which information goes into which field?  For instance, if we want to say the BOM Assembly Revision is the "Batch" information, and put it in field (a), can we do that?  Then the Work Order plus 3 digits would be considered the "Serial Number" and would go in field (b)?

Thanks!

You asked, “If we want to call the BOM assembly revision the "batch", we can do that right, and put that revision letter in the "batch" field of the UDI?” It looks likes the answer is no, because the UDI rule defines lot or batch.

801.3 Lot or batch means one finished device or more that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.

Based on your description, it looks like you might not satisfy the “manufactured under essentially the same conditions” clause. If have a BOM assembly revision, I expect you will issue multiple production orders. Each one of them would define the lot or batch.

I also wonder why you would want to start using PIs when you don’t have them already. Since they are not required and don’t add value to your organization, my impression is that they would be non-valued added activities. UDI is not for the manufacturer, but for the customer. My general advice is unless the customer needs the information, don’t put it into your UDI implementation

You asked, “If we want to call the BOM assembly revision the "batch", we can do that right, and put that revision letter in the "batch" field of the UDI?” It looks likes the answer is no, because the UDI rule defines lot or batch.

801.3 Lot or batch means one finished device or more that consist of a single type, model, class, size, composition, or software version that are manufactured under essentially the same conditions and that are intended to have uniform characteristics and quality within specified limits.

Based on your description, it looks like you might not satisfy the “manufactured under essentially the same conditions” clause. If have a BOM assembly revision, I expect you will issue multiple production orders. Each one of them would define the lot or batch.

I also wonder why you would want to start using PIs when you don’t have them already. Since they are not required and don’t add value to your organization, my impression is that they would be non-valued added activities. UDI is not for the manufacturer, but for the customer. My general advice is unless the customer needs the information, don’t put it into your UDI implementation

Thanks for pointing out that definition Dan. 

The reason for my question is to try and avoid redundancy.  Currently, we DO track PIs. An example of a current Serial Number is the following:

Model#BOMRevisionWorkOrderNumber001

We could leave the Serial Number as-is, or I could try to break it out into its components to avoid redundancy in the UDI.  Just trying to see which fields I can put everything.  I hope this clarifies my intent!

The current UDI Final Rule states the following PI information as variable:

(a) The Lot or Batch within which a device was manufactured

(b) The Serial Number

(c) The Expiration Date

(d) the Manufacture Date

(e) stuff for an HCT/P device not applicable to us

Currently, we tack the following information on an internal bar code:

1) Serial Number, which includes the Model Number and Work order number (essentially our Lot information). 

2) BOM Assembly Revision 

To merge this data into the UDI format, may we pick which information goes into which field?  For instance, if we want to say the BOM Assembly Revision is the "Batch" information, and put it in field (a), can we do that?  Then the Work Order plus 3 digits would be considered the "Serial Number" and would go in field (b)?

Thanks!

The current UDI Final Rule states the following PI information as variable:

(a) The Lot or Batch within which a device was manufactured

(b) The Serial Number

(c) The Expiration Date

(d) the Manufacture Date

(e) stuff for an HCT/P device not applicable to us

Currently, we tack the following information on an internal bar code:

1) Serial Number, which includes the Model Number and Work order number (essentially our Lot information). 

2) BOM Assembly Revision 

To merge this data into the UDI format, may we pick which information goes into which field?  For instance, if we want to say the BOM Assembly Revision is the "Batch" information, and put it in field (a), can we do that?  Then the Work Order plus 3 digits would be considered the "Serial Number" and would go in field (b)?

Thanks!

I see a potential issue if you make your devices in lots or batches. The usual expectation is that the serial number is unique to the device. I looked at your listing quickly and I would guess that each work order makes a single device. I would not expect a company to make NMR Imaging systems, for example, in batches.

The second issue is the length (number of characters). FDA doesn’t care because you don’t enter the serial number into GUDID.

However the Issuing Agencies have maximums. You example is 35 characters, but I infer this is the structure and not an actual serial number.

For GS1 the maximum length is 22 characters for data delimiter (21)

For HIBCC the maximum length is 20 characters for data delimiter $+

For ICCBBA the maximum length is 8 characters for data delimiter =,