This message was posted by a user wishing to remain anonymous
You may need to justify the extent to which a cadaver is equivalent to a live patient in your particular application.
The ethics does not currently have strict rules, beyond treating the remains with respect.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6900127/
https://pubmed.ncbi.nlm.nih.gov/29139057/
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9362629/
Original Message:
Sent: 05-Mar-2024 13:54
From: Anonymous Member
Subject: Standards for use of cadavers in usability testing?
This message was posted by a user wishing to remain anonymous
Hello All,
I too am looking for some regulatory guidelines and/or other information on the use of cadavers for studies, specifically to support a 510(k) submission for a different device type than the original post.
Original Message:
Sent: 09-Jan-2019 11:10
From: Anonymous Member
Subject: Standards for use of cadavers in usability testing?
This message was posted by a user wishing to remain anonymous
Good morning, All
Can anyone point me in the direction of regulatory guidelines and information on the use of cadavers. This use is being proposed for usability testing of a pre-filled syringe?
Thanks so much.