Regulatory Open Forum

What is your experience with preparation of IFUs? Is this generally handled by Sales/Marketing,  Engineering, and/or Regulatory? Does Regulatory or Quality generally approve these documents?

Currently we control these documents but they are often are pushed through the system without regulatory review.  As a regulatory professional, what do you generally look for during a review of IFUs if you are involved in the process?

As a general rule, Regulatory and Quality ALWAYS need to be part of the approval of IFUs.  In the device space, the full product is generally considered to be the device, its labeling, and its packaging. IFUs are considered to be labeling, and labeling is carefully regulated by specific regulatory requirements such as, in the USA, 21 CFR Parts 801 & 830 (general labeling and UDI), 807 [regarding 510(k)s], 814 (regarding PMAs),809 (IVD labeling), etc.  Critical aspects of the IFU have profound regulatory and quality (i.e., public health) implications, such as the labeled intended use, indications for use, claims (advertising is part of labeling), warnings, precautions, contraindications, etc., etc. Accordingly, it is essentially a regulatory requirement that Regulatory and Quality be part of IFU approval.  And because of the cross-functional risk-based derivation of the labeling, it also generally means that Engineering needs to be involved, as they are pivotal in participating in the risk management/control process. Moreover, labeling changes are design/engineering changes, again reminding us of the need for cross-functional involvement.

Sales/Marketing certainly is often the initiator of IFU changes.  But it is generally violative if Sales/Marketing do those changes in a vacuum without cross-functional participation from the other design team members. An isolated Sales/Marketing team in a regulated environment is a recipe for Warning Letters, recalls, and other regulatory mishaps. Indeed, labeling is a critical design output.  Mature/experienced Sales/Marketing teams general understand this and have grown to accept the involvement of additional team members.  Newer organizations where the Sales/Marketing personnel might not before have been exposed much to a regulated space will require additional training/development of those personnel to help them become more fluent in the fact that IFUs are heavily regulated artifacts demanding ongoing regulatory involvement in perpetuity.

What is your experience with preparation of IFUs? Is this generally handled by Sales/Marketing,  Engineering, and/or Regulatory? Does Regulatory or Quality generally approve these documents?

Currently we control these documents but they are often are pushed through the system without regulatory review.  As a regulatory professional, what do you generally look for during a review of IFUs if you are involved in the process?

As a general rule, Regulatory and Quality ALWAYS need to be part of the approval of IFUs.  In the device space, the full product is generally considered to be the device, its labeling, and its packaging. IFUs are considered to be labeling, and labeling is carefully regulated by specific regulatory requirements such as, in the USA, 21 CFR Parts 801 & 830 (general labeling and UDI), 807 [regarding 510(k)s], 814 (regarding PMAs),809 (IVD labeling), etc.  Critical aspects of the IFU have profound regulatory and quality (i.e., public health) implications, such as the labeled intended use, indications for use, claims (advertising is part of labeling), warnings, precautions, contraindications, etc., etc. Accordingly, it is essentially a regulatory requirement that Regulatory and Quality be part of IFU approval.  And because of the cross-functional risk-based derivation of the labeling, it also generally means that Engineering needs to be involved, as they are pivotal in participating in the risk management/control process. Moreover, labeling changes are design/engineering changes, again reminding us of the need for cross-functional involvement.

Sales/Marketing certainly is often the initiator of IFU changes.  But it is generally violative if Sales/Marketing do those changes in a vacuum without cross-functional participation from the other design team members. An isolated Sales/Marketing team in a regulated environment is a recipe for Warning Letters, recalls, and other regulatory mishaps. Indeed, labeling is a critical design output.  Mature/experienced Sales/Marketing teams general understand this and have grown to accept the involvement of additional team members.  Newer organizations where the Sales/Marketing personnel might not before have been exposed much to a regulated space will require additional training/development of those personnel to help them become more fluent in the fact that IFUs are heavily regulated artifacts demanding ongoing regulatory involvement in perpetuity.

What is your experience with preparation of IFUs? Is this generally handled by Sales/Marketing,  Engineering, and/or Regulatory? Does Regulatory or Quality generally approve these documents?

Currently we control these documents but they are often are pushed through the system without regulatory review.  As a regulatory professional, what do you generally look for during a review of IFUs if you are involved in the process?

While I agree 99.9% with Kevin's post listing those who need to be a part of IFU development and review, I have one issue. While engineering is one part of the cross-functional risk management team, there are others that must be involved from a risk management perspective. Clinical/ medical and legal members of the risk management team for instance, and the choice of risk management participation should be done by the person responsible for the risk management system and not be limited to engineering. 

As a general rule, Regulatory and Quality ALWAYS need to be part of the approval of IFUs.  In the device space, the full product is generally considered to be the device, its labeling, and its packaging. IFUs are considered to be labeling, and labeling is carefully regulated by specific regulatory requirements such as, in the USA, 21 CFR Parts 801 & 830 (general labeling and UDI), 807 [regarding 510(k)s], 814 (regarding PMAs),809 (IVD labeling), etc.  Critical aspects of the IFU have profound regulatory and quality (i.e., public health) implications, such as the labeled intended use, indications for use, claims (advertising is part of labeling), warnings, precautions, contraindications, etc., etc. Accordingly, it is essentially a regulatory requirement that Regulatory and Quality be part of IFU approval.  And because of the cross-functional risk-based derivation of the labeling, it also generally means that Engineering needs to be involved, as they are pivotal in participating in the risk management/control process. Moreover, labeling changes are design/engineering changes, again reminding us of the need for cross-functional involvement.

Sales/Marketing certainly is often the initiator of IFU changes.  But it is generally violative if Sales/Marketing do those changes in a vacuum without cross-functional participation from the other design team members. An isolated Sales/Marketing team in a regulated environment is a recipe for Warning Letters, recalls, and other regulatory mishaps. Indeed, labeling is a critical design output.  Mature/experienced Sales/Marketing teams general understand this and have grown to accept the involvement of additional team members.  Newer organizations where the Sales/Marketing personnel might not before have been exposed much to a regulated space will require additional training/development of those personnel to help them become more fluent in the fact that IFUs are heavily regulated artifacts demanding ongoing regulatory involvement in perpetuity.

What is your experience with preparation of IFUs? Is this generally handled by Sales/Marketing,  Engineering, and/or Regulatory? Does Regulatory or Quality generally approve these documents?

Currently we control these documents but they are often are pushed through the system without regulatory review.  As a regulatory professional, what do you generally look for during a review of IFUs if you are involved in the process?

What is your experience with preparation of IFUs? Is this generally handled by Sales/Marketing,  Engineering, and/or Regulatory? Does Regulatory or Quality generally approve these documents?

Currently we control these documents but they are often are pushed through the system without regulatory review.  As a regulatory professional, what do you generally look for during a review of IFUs if you are involved in the process?

What is your experience with preparation of IFUs? Is this generally handled by Sales/Marketing,  Engineering, and/or Regulatory? Does Regulatory or Quality generally approve these documents?

Currently we control these documents but they are often are pushed through the system without regulatory review.  As a regulatory professional, what do you generally look for during a review of IFUs if you are involved in the process?

What is your experience with preparation of IFUs? Is this generally handled by Sales/Marketing,  Engineering, and/or Regulatory? Does Regulatory or Quality generally approve these documents?

Currently we control these documents but they are often are pushed through the system without regulatory review.  As a regulatory professional, what do you generally look for during a review of IFUs if you are involved in the process?

What is your experience with preparation of IFUs? Is this generally handled by Sales/Marketing,  Engineering, and/or Regulatory? Does Regulatory or Quality generally approve these documents?

Currently we control these documents but they are often are pushed through the system without regulatory review.  As a regulatory professional, what do you generally look for during a review of IFUs if you are involved in the process?

While Regulatory/Quality needs to be a key approver, that doesn't mean Sales/Marketing should be excluded.  Specifically, all of Sales/Marketing's advertising collateral will be bound by the cleared/approved regulatory intended use and indications embodied in the IFU.  Accordingly, it is critical that Sales/Marketing be allowed as a contributing co-author and co-approver of the IFU's stated intended use and indications so as to facilitate alignment between Sales/Marketing's ad campaigns and the product's regulatory boundaries.  In addition, the Sales/Marketing team is often the most informed voice of the customer with respect to the user palatability/feasibility of certain usage paradigms, contraindications, warnings, etc.  Therefore both departments need to be involved (in addition perhaps to others who are outside the scope of Anon's immediate question).

What is your experience with preparation of IFUs? Is this generally handled by Sales/Marketing,  Engineering, and/or Regulatory? Does Regulatory or Quality generally approve these documents?

Currently we control these documents but they are often are pushed through the system without regulatory review.  As a regulatory professional, what do you generally look for during a review of IFUs if you are involved in the process?