14971:2019 added a definition for reasonably foreseeable misuse, "use of a product or system in a way not intended by the manufacturer, but which can result from readily predictable human behavior". This needs to consider all types of users and can be intentional or unintentional. I think there are several things at play in the question.
Here is a link to an FDA guidance on responding to unsolicited requests for off label information
https://www.fda.gov/media/82660/download FDA expects manufacturers to field these requests with truthful, balanced, nonmisleading and non-promotional information. This includes communicating the risks involved with the off-label use, implying that the manufacturer has considered it.
Manufacturer implementation of ISO 14971 is quite variable. Manufacturers I work with require a cross functional team to be involved in the risk management process to ensure things are not missed. Particularly important is the medical affairs that usually provide the hazard analysis on the front end of the process and sign off on the overall results on the back end, at a minimum. One of the inputs to the process is post market surveillance, where off label use may surface. It seems reasonable to me that a risk management team would consider the off label use and assess the risk per usual and decide which, if any, additional risk mitigations need to be considered. Ignoring post market information will get a manufacturer in trouble, for sure.
Hope it helps.
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Adam Atherton
Farragut TN
United States
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Original Message:
Sent: 27-Mar-2020 08:23
From: Anonymous Member
Subject: Risk Management & Off Label Use
This message was posted by a user wishing to remain anonymous
My colleagues and I are discussing the 14971 part about foreseeable misuse.
Some people think that if we know about off-label use, that is foreseeable misuse and we need to include it.
Some people think that including it means supporting it, because the risk management would look at any issues. If FDA finds out, they could take action against the company.
I'd like to hear how others handle this issue.