Regulatory Open Forum

ISO 14971:2019 asks the manufacturer to consider reasonably foreseeable misuse.

I'm always nervous about considering reasonably foreseeable misuse might be, in fact, condoning off-label use. Some regulatory jurisdictions have rules, regulations, and requirements in this area.

I have not kept up with the current state of regulatory thinking in this area.

What is the current thinking for a manufacturer's obligations when
a) condoning off-label use
b) learning of unexpected off-label use (perhaps from a complaint)

How does reasonably foreseeably misuse fit into regulatory thinking?

To limit the scope, for, what I anticipate is complicated issue, consider the MDSAP countries and, perhaps, the EU.

ISO 14971:2019 asks the manufacturer to consider reasonably foreseeable misuse.

I'm always nervous about considering reasonably foreseeable misuse might be, in fact, condoning off-label use. Some regulatory jurisdictions have rules, regulations, and requirements in this area.

I have not kept up with the current state of regulatory thinking in this area.

What is the current thinking for a manufacturer's obligations when
a) condoning off-label use
b) learning of unexpected off-label use (perhaps from a complaint)

How does reasonably foreseeably misuse fit into regulatory thinking?

To limit the scope, for, what I anticipate is complicated issue, consider the MDSAP countries and, perhaps, the EU.

ISO 14971:2019 asks the manufacturer to consider reasonably foreseeable misuse.

I'm always nervous about considering reasonably foreseeable misuse might be, in fact, condoning off-label use. Some regulatory jurisdictions have rules, regulations, and requirements in this area.

I have not kept up with the current state of regulatory thinking in this area.

What is the current thinking for a manufacturer's obligations when
a) condoning off-label use
b) learning of unexpected off-label use (perhaps from a complaint)

How does reasonably foreseeably misuse fit into regulatory thinking?

To limit the scope, for, what I anticipate is complicated issue, consider the MDSAP countries and, perhaps, the EU.

ISO 14971:2019 asks the manufacturer to consider reasonably foreseeable misuse.

I'm always nervous about considering reasonably foreseeable misuse might be, in fact, condoning off-label use. Some regulatory jurisdictions have rules, regulations, and requirements in this area.

I have not kept up with the current state of regulatory thinking in this area.

What is the current thinking for a manufacturer's obligations when
a) condoning off-label use
b) learning of unexpected off-label use (perhaps from a complaint)

How does reasonably foreseeably misuse fit into regulatory thinking?

To limit the scope, for, what I anticipate is complicated issue, consider the MDSAP countries and, perhaps, the EU.

ISO 14971:2019 asks the manufacturer to consider reasonably foreseeable misuse.

I'm always nervous about considering reasonably foreseeable misuse might be, in fact, condoning off-label use. Some regulatory jurisdictions have rules, regulations, and requirements in this area.

I have not kept up with the current state of regulatory thinking in this area.

What is the current thinking for a manufacturer's obligations when
a) condoning off-label use
b) learning of unexpected off-label use (perhaps from a complaint)

How does reasonably foreseeably misuse fit into regulatory thinking?

To limit the scope, for, what I anticipate is complicated issue, consider the MDSAP countries and, perhaps, the EU.

ISO 14971:2019 asks the manufacturer to consider reasonably foreseeable misuse.

I'm always nervous about considering reasonably foreseeable misuse might be, in fact, condoning off-label use. Some regulatory jurisdictions have rules, regulations, and requirements in this area.

I have not kept up with the current state of regulatory thinking in this area.

What is the current thinking for a manufacturer's obligations when
a) condoning off-label use
b) learning of unexpected off-label use (perhaps from a complaint)

How does reasonably foreseeably misuse fit into regulatory thinking?

To limit the scope, for, what I anticipate is complicated issue, consider the MDSAP countries and, perhaps, the EU.

ISO 14971:2019 asks the manufacturer to consider reasonably foreseeable misuse.

I'm always nervous about considering reasonably foreseeable misuse might be, in fact, condoning off-label use. Some regulatory jurisdictions have rules, regulations, and requirements in this area.

I have not kept up with the current state of regulatory thinking in this area.

What is the current thinking for a manufacturer's obligations when
a) condoning off-label use
b) learning of unexpected off-label use (perhaps from a complaint)

How does reasonably foreseeably misuse fit into regulatory thinking?

To limit the scope, for, what I anticipate is complicated issue, consider the MDSAP countries and, perhaps, the EU.

ISO 14971:2019 asks the manufacturer to consider reasonably foreseeable misuse.

I'm always nervous about considering reasonably foreseeable misuse might be, in fact, condoning off-label use. Some regulatory jurisdictions have rules, regulations, and requirements in this area.

I have not kept up with the current state of regulatory thinking in this area.

What is the current thinking for a manufacturer's obligations when
a) condoning off-label use
b) learning of unexpected off-label use (perhaps from a complaint)

How does reasonably foreseeably misuse fit into regulatory thinking?

To limit the scope, for, what I anticipate is complicated issue, consider the MDSAP countries and, perhaps, the EU.

ISO 14971:2019 asks the manufacturer to consider reasonably foreseeable misuse.

I'm always nervous about considering reasonably foreseeable misuse might be, in fact, condoning off-label use. Some regulatory jurisdictions have rules, regulations, and requirements in this area.

I have not kept up with the current state of regulatory thinking in this area.

What is the current thinking for a manufacturer's obligations when
a) condoning off-label use
b) learning of unexpected off-label use (perhaps from a complaint)

How does reasonably foreseeably misuse fit into regulatory thinking?

To limit the scope, for, what I anticipate is complicated issue, consider the MDSAP countries and, perhaps, the EU.

ISO 14971:2019 asks the manufacturer to consider reasonably foreseeable misuse.

I'm always nervous about considering reasonably foreseeable misuse might be, in fact, condoning off-label use. Some regulatory jurisdictions have rules, regulations, and requirements in this area.

I have not kept up with the current state of regulatory thinking in this area.

What is the current thinking for a manufacturer's obligations when
a) condoning off-label use
b) learning of unexpected off-label use (perhaps from a complaint)

How does reasonably foreseeably misuse fit into regulatory thinking?

To limit the scope, for, what I anticipate is complicated issue, consider the MDSAP countries and, perhaps, the EU.

ISO 14971:2019 asks the manufacturer to consider reasonably foreseeable misuse.

I'm always nervous about considering reasonably foreseeable misuse might be, in fact, condoning off-label use. Some regulatory jurisdictions have rules, regulations, and requirements in this area.

I have not kept up with the current state of regulatory thinking in this area.

What is the current thinking for a manufacturer's obligations when
a) condoning off-label use
b) learning of unexpected off-label use (perhaps from a complaint)

How does reasonably foreseeably misuse fit into regulatory thinking?

To limit the scope, for, what I anticipate is complicated issue, consider the MDSAP countries and, perhaps, the EU.

ISO 14971:2019 asks the manufacturer to consider reasonably foreseeable misuse.

I'm always nervous about considering reasonably foreseeable misuse might be, in fact, condoning off-label use. Some regulatory jurisdictions have rules, regulations, and requirements in this area.

I have not kept up with the current state of regulatory thinking in this area.

What is the current thinking for a manufacturer's obligations when
a) condoning off-label use
b) learning of unexpected off-label use (perhaps from a complaint)

How does reasonably foreseeably misuse fit into regulatory thinking?

To limit the scope, for, what I anticipate is complicated issue, consider the MDSAP countries and, perhaps, the EU.

Thank you all for the comments and information.

I'm particularly concerned by the guidance document that Anne cited, "If a manufacturer knows or has information indicating that his device is to be used for conditions or purposes other than which it was intended, he is required to provide adequate labeling in accordance with such other uses. (An example of this might be a manufacturer of dental X-ray equipment who is routinely selling his product to podiatrists.)"

There is ambiguity here since it starts as "the manufacturer knows" but the example is "the manufacturer sells". I think of reasonably foreseeable misuse as falling into the "knows" portion. It is what makes me nervous and I usually recommend that people who address this in the Risk Management File have a consultation with the company's Regulatory folk.

Ella's situation is a good case in point. If a customer misuses a device, the obligation falls on the manufacturer.

In my opinion, this is a bad policy from FDA. As I recall, there was a time when the manufacturer had to send a letter to the user telling to stop the misuse.

Also, IEC 62366-1, 4.1.3 says, "Conscious disregard of such information for safety by the user is considered to be an intentional act or intentional omission of an act that is counter to or violates normal use and  is also beyond any further reasonable means of user interface-related risk control by the manufacturer (i.e., abnormal use)".

I think of this as extending to other forms of abnormal use – conscious, intentional act or intentional omission of an act that is counter to or violates normal use

ISO 14971:2019 asks the manufacturer to consider reasonably foreseeable misuse.

I'm always nervous about considering reasonably foreseeable misuse might be, in fact, condoning off-label use. Some regulatory jurisdictions have rules, regulations, and requirements in this area.

I have not kept up with the current state of regulatory thinking in this area.

What is the current thinking for a manufacturer's obligations when
a) condoning off-label use
b) learning of unexpected off-label use (perhaps from a complaint)

How does reasonably foreseeably misuse fit into regulatory thinking?

To limit the scope, for, what I anticipate is complicated issue, consider the MDSAP countries and, perhaps, the EU.

Thank you all for the comments and information.

I'm particularly concerned by the guidance document that Anne cited, "If a manufacturer knows or has information indicating that his device is to be used for conditions or purposes other than which it was intended, he is required to provide adequate labeling in accordance with such other uses. (An example of this might be a manufacturer of dental X-ray equipment who is routinely selling his product to podiatrists.)"

There is ambiguity here since it starts as "the manufacturer knows" but the example is "the manufacturer sells". I think of reasonably foreseeable misuse as falling into the "knows" portion. It is what makes me nervous and I usually recommend that people who address this in the Risk Management File have a consultation with the company's Regulatory folk.

Ella's situation is a good case in point. If a customer misuses a device, the obligation falls on the manufacturer.

In my opinion, this is a bad policy from FDA. As I recall, there was a time when the manufacturer had to send a letter to the user telling to stop the misuse.

Also, IEC 62366-1, 4.1.3 says, "Conscious disregard of such information for safety by the user is considered to be an intentional act or intentional omission of an act that is counter to or violates normal use and  is also beyond any further reasonable means of user interface-related risk control by the manufacturer (i.e., abnormal use)".

I think of this as extending to other forms of abnormal use – conscious, intentional act or intentional omission of an act that is counter to or violates normal use

ISO 14971:2019 asks the manufacturer to consider reasonably foreseeable misuse.

I'm always nervous about considering reasonably foreseeable misuse might be, in fact, condoning off-label use. Some regulatory jurisdictions have rules, regulations, and requirements in this area.

I have not kept up with the current state of regulatory thinking in this area.

What is the current thinking for a manufacturer's obligations when
a) condoning off-label use
b) learning of unexpected off-label use (perhaps from a complaint)

How does reasonably foreseeably misuse fit into regulatory thinking?

To limit the scope, for, what I anticipate is complicated issue, consider the MDSAP countries and, perhaps, the EU.

Thank you all for the comments and information.

I'm particularly concerned by the guidance document that Anne cited, "If a manufacturer knows or has information indicating that his device is to be used for conditions or purposes other than which it was intended, he is required to provide adequate labeling in accordance with such other uses. (An example of this might be a manufacturer of dental X-ray equipment who is routinely selling his product to podiatrists.)"

There is ambiguity here since it starts as "the manufacturer knows" but the example is "the manufacturer sells". I think of reasonably foreseeable misuse as falling into the "knows" portion. It is what makes me nervous and I usually recommend that people who address this in the Risk Management File have a consultation with the company's Regulatory folk.

Ella's situation is a good case in point. If a customer misuses a device, the obligation falls on the manufacturer.

In my opinion, this is a bad policy from FDA. As I recall, there was a time when the manufacturer had to send a letter to the user telling to stop the misuse.

Also, IEC 62366-1, 4.1.3 says, "Conscious disregard of such information for safety by the user is considered to be an intentional act or intentional omission of an act that is counter to or violates normal use and  is also beyond any further reasonable means of user interface-related risk control by the manufacturer (i.e., abnormal use)".

I think of this as extending to other forms of abnormal use – conscious, intentional act or intentional omission of an act that is counter to or violates normal use

ISO 14971:2019 asks the manufacturer to consider reasonably foreseeable misuse.

I'm always nervous about considering reasonably foreseeable misuse might be, in fact, condoning off-label use. Some regulatory jurisdictions have rules, regulations, and requirements in this area.

I have not kept up with the current state of regulatory thinking in this area.

What is the current thinking for a manufacturer's obligations when
a) condoning off-label use
b) learning of unexpected off-label use (perhaps from a complaint)

How does reasonably foreseeably misuse fit into regulatory thinking?

To limit the scope, for, what I anticipate is complicated issue, consider the MDSAP countries and, perhaps, the EU.