FDA Medical Device Label Requirements - serial numbers

#1
Hello all,

I've spent the greater part of my entire day and evening trying to find a clear answer to provide to my manager on Monday about the requirements for including serial numbers, manufacturing date, expiry date, lot/batch number, etc. on medical device labeling.

We already know the standard information that is required on the label such as, name and place of business of us (mfg.), including street address, city, state, zip code, etc. etc.

The primary concern is what is required in our UDI. I know from my research that the UDI for our type of device consists of two parts: DI and the PI. The PI is a conditional, variable portion of the UDI that identifies any one or more of five aspects (lot/batch, serial number, expiration, manufacture date, HCT/P ID number) IF those aspects are on the device label.

My question is...what dictates which of these five aspects we include on our device labeling? This is a class II device, it is reusable, electrified, non-sterile device that's intended purpose is therapeutic (physical medicine) in nature (not in-vitro diagnostic). Also, this device does not meet the requirements for traceability as defined in 820.65 as it is not intended for surgical implant into the body or to support or sustain life.

This is a new device that is still in the design phase so we are just now starting to consider labeling, which is why we are just now starting to think about what information we should include on the labeling and within our UDI.

I realize that the dFMEA will play a role in the content of our labeling, but is it just that or is there more for us to go on (guidance document I possibly haven't come across?) to determine, for instance, if it's most appropriate to include the serial number versus just the lot/batch number? I will say that it has been expressed by members of our team that the preference is to not include the serial number as long as we include the lot/batch number (our lots are relatively small, if that matters to you), so I'm trying to formulate an educated opinion on whether to support that or not.

One person within our organization has mentioned that the choice to include the serial number versus the lot number is to help limit the scope of a recall. I've no experience with recalls (thankfully but also not), so I can't even really say if thats a true statement. I feel like the root cause of the recall and our specific manufacturing process would have more to do with the scope of the recall than the identifier used to trace a single device for which we've identified an issue. I feel as though regardless of whether we have the lot number or the serial number on the label, one of the two should be sufficient. I prefer we use the lot number (no reason other than that's what I've seen before which means little to nothing), but really just want to do what is best. What would be a justifiable reason for having both the lot and the serial number on the label (and therefore in the UDI), or is it the opinion that one of the two are sufficient?

Any help is appreciated!
 

Al Rosen

Staff member
Super Moderator
#3
Hello all,

I've spent the greater part of my entire day and evening trying to find a clear answer to provide to my manager on Monday about the requirements for including serial numbers, manufacturing date, expiry date, lot/batch number, etc. on medical device labeling.

We already know the standard information that is required on the label such as, name and place of business of us (mfg.), including street address, city, state, zip code, etc. etc.

The primary concern is what is required in our UDI. I know from my research that the UDI for our type of device consists of two parts: DI and the PI. The PI is a conditional, variable portion of the UDI that identifies any one or more of five aspects (lot/batch, serial number, expiration, manufacture date, HCT/P ID number) IF those aspects are on the device label.

My question is...what dictates which of these five aspects we include on our device labeling? This is a class II device, it is reusable, electrified, non-sterile device that's intended purpose is therapeutic (physical medicine) in nature (not in-vitro diagnostic). Also, this device does not meet the requirements for traceability as defined in 820.65 as it is not intended for surgical implant into the body or to support or sustain life.

This is a new device that is still in the design phase so we are just now starting to consider labeling, which is why we are just now starting to think about what information we should include on the labeling and within our UDI.

I realize that the dFMEA will play a role in the content of our labeling, but is it just that or is there more for us to go on (guidance document I possibly haven't come across?) to determine, for instance, if it's most appropriate to include the serial number versus just the lot/batch number? I will say that it has been expressed by members of our team that the preference is to not include the serial number as long as we include the lot/batch number (our lots are relatively small, if that matters to you), so I'm trying to formulate an educated opinion on whether to support that or not.

One person within our organization has mentioned that the choice to include the serial number versus the lot number is to help limit the scope of a recall. I've no experience with recalls (thankfully but also not), so I can't even really say if thats a true statement. I feel like the root cause of the recall and our specific manufacturing process would have more to do with the scope of the recall than the identifier used to trace a single device for which we've identified an issue. I feel as though regardless of whether we have the lot number or the serial number on the label, one of the two should be sufficient. I prefer we use the lot number (no reason other than that's what I've seen before which means little to nothing), but really just want to do what is best. What would be a justifiable reason for having both the lot and the serial number on the label (and therefore in the UDI), or is it the opinion that one of the two are sufficient?

Any help is appreciated!
In my opinion, you should use either the lot number or serial number, not both. Using both is unnecessarily complicated. If you have small lots, use the lot/batch number. I don't know your manufacturing process and where in your process you apply your labels or if you know the serial number of each device at the beginning of the process. Recalls occur infrequently, but you have to live with the process every day, so do what's easier for you while still meeting the requirements.
 

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