Hi Sabrina,
Depending on when the carton is expected to be removed, the required information from 801 would be all you need for the device label except for lot traceability information (lot/expiration). If the carton is staying with the product until use or an insert is with the product that contains the adequate directions for use and warnings, I wouldn't expect a lot of information to be needed on the tray itself.
Anyone else have a different opinion?
Hope that helps.
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Maddi Myers
Regulatory and Quality Project Manager
Carver MN
United States
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Original Message:
Sent: 22-Aug-2019 17:50
From: Sabrina Dessources
Subject: Combination Product-device constituent labeling
Hi everyone,
Do you know of any FDA guidance documents on combination product labeling? The combination product is a co-packaged biologic/device. The biologic and device constituents will be in packaged in a "tray like" container with 2 compartments, one for the biologic constituent container and the other for the device constituent; the compartment containing the device will be covered with a protective tyvek lid. I am trying to understand the minimum labeling information that's required/expected on the tyvek. The labeling requirements for the carton label (overall combination product) is fairly clear but the requirements for the device constituent are not clear. The PMOA is the biologic so a BLA will be submitted.
21 CFR 801 provides some information but I am trying to make sure that I have everything (as far as I know) covered.
Any guidance is appreciated.
Thanks for your help!
Sabrina
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Sabrina Dessources
Boston MA
United States
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