Three Questions on Finished Medical Device Traceability, Labeling and Packaging

[maryacton]

Sorry for asking so many questions -

1. Is the “Country of Origin” needed to be mentioned on all packaging materials supporting a finished medical device ? We have a customer packagaing that mentions the Customers address in US but does not have specific reference to “Country of Origin”. Under what circumstances if the “Country of Origin” required ?

2. Being into plastic injection molding for medical devices, we assign a Lot Number for the weekly running of the products but the manufacturing date keeps changing based on the actual date olf molding. Is this practise acceptable to have the same Lot number with different manufacturing dates ? My gut says its fine but when I read the FDA definition of “Lot” I felt it to be not okay.

3. We get printed product bags from the supplier and then we pack the product in it and put a sticker having batch details. Is the practise of affixing sticker with product detail acceptable in the US per FDA requirements ? I am asking this question as some countries do not allow stickets and want batch details to be overprinted.

[yodon]

@maryacton

Sorry for asking so many questions -

It’s not the number, it’s the degree of difficulty!

@maryacton

1. Is the “Country of Origin” needed to be mentioned on all packaging materials supporting a finished medical device ? We have a customer packagaing that mentions the Customers address in US but does not have specific reference to “Country of Origin”. Under what circumstances if the “Country of Origin” required ?

Presume since other questions mention FDA / US, you’re particularly concerned with US regulation. A quick scan of the labeling regulation (21 CFR 801:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRPart=801
) doesn’t seem to indicate that country of origin is required. This should be confirmed with a regulatory expert, though.

@maryacton

2. Being into plastic injection molding for medical devices, we assign a Lot Number for the weekly running of the products but the manufacturing date keeps changing based on the actual date olf molding. Is this practise acceptable to have the same Lot number with different manufacturing dates ? My gut says its fine but when I read the FDA definition of “Lot” I felt it to be not okay.

In the above regulation, lot is defined “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.” So if you can defend that the conditions are met (essentially same conditions and uniform characteristics / quality) then it would seem ok.

@maryacton

3. We get printed product bags from the supplier and then we pack the product in it and put a sticker having batch details. Is the practise of affixing sticker with product detail acceptable in the US per FDA requirements ? I am asking this question as some countries do not allow stickets and want batch details to be overprinted.

Another one for a regulatory expert but it would seem if the regulation is met (including a validation that the stickers stay where placed and remain legible through anticipated conditions (heat / cold / humidity from shipping, etc.) you should be in a defensible position.

Maybe someone with particular experience with these scenarios will chime in.