Anon,
Indeed in the United States there is a clear distinction between Research Use Only - which is for non-human/subject use - and Investigational Use Only - which is for human/subject use. For investigational products, this must conform with the labelling requirements specific in 21 CFR 812 (and 21 CFR 801).
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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 06-Sep-2023 09:22
From: Anonymous Member
Subject: CLINICAL TRAIL
This message was posted by a user wishing to remain anonymous
If it is for human research, you must change to what is stipulated in CFR........Investigation use only.......
Original Message:
Sent: 06-Sep-2023 08:44
From: Anonymous Member
Subject: CLINICAL TRAIL
This message was posted by a user wishing to remain anonymous
Hi Everyone,
Do we need to change the product label from 'RUO' (Research Use Only) to 'Investigation Use Only' when sending our product, which we manufacture in Europe, to a US site for a clinical trial, or can we retain the 'RUO' label.
Thanks.