Hello Anon,
Personally I have not seen a request like this for a 510(k) submission where the standard needs to be on the actual product package label; I have seen this type of information listed in the IFU. Though have a couple responses to send back to you. What applicable standard of material are you speaking about, you mean like if stainless steel is listed as SS304 or SS316 on the package or like meeting ASTM A580? Also this can be dependent on the device type, so without knowing types of material, might be a little difficult to answer. However, I have seen some reviewers especially in Europe wanting to see certain material descriptions listed on the product package label, not necessarily a standard which complies, but the material description or material composition of the product, i.e. like for implants.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 07-Sep-2021 10:46
From: Anonymous Member
Subject: Material Standards on Package Label
This message was posted by a user wishing to remain anonymous
Hi,
During a recent 510(k) submission, we received a request from the FDA that we add the applicable standard for each material listed on the product package label. (Class II Medical Device) Have any of you seen this as well? If the standards are listed in the IFU, why would they need to be listed on the package label?
Thanks