In December, the FDA published updated draft guidance on HF content in device submissions. The FDA says it will help them better understand the potential risks of user error and how they can potentially be mitigated. The agency said it uses a risk-based approach in its proposed guidance, but the Medical Device Manufacturers Association (MDMA) disagreed in public comment. FDA Proposes Framework for Human Factors Information in Device Submissions, Regulatory focus December 12, 2022)
The MDMA recognizes that FDA typically takes a risk-based approach in its regulatory process, and follows congressional direction to take the least burdensome approach, but the guidance achieves those goals. He claims he can’t.
“MDMA believes that elements of the draft guidance inappropriately deviate from this broad risk-based approach, contradict the underlying principles of the premarket review framework, and, as a result, cause agencies to divert their limited resources. We believe it will result in focusing on human factors information that has not been adjusted to address the situation that poses the highest risk to patients,” said the MDA. “Although the draft guidance aims to adopt a ‘risk-based approach’, the draft guidance states that the existence of significant new or changed tasks, ignoring other relevant factors that should inform risk, It provides for determining the human factors information required for premarket submissions.
The MDMA is concerned that the draft guidance will significantly expand the scope of premarket submissions for medical devices that FDA requires for HF information, resulting in a review of what is considered necessary HF information prior to submission with FDA. This would not only unnecessarily burden sponsors, but would further strain the FDA’s limited premarket review resources, they argue.
MDMA also argues that the FDA should consider device type when assessing the level of risk from HF when evaluating products. The group said the guidance should take into account the types of HF information needed to support premarket submissions and clarify the nature of the information needed for regulatory decisions.
“A suitable risk-based approach, consistent with existing regulatory frameworks, should be considered by manufacturers regarding the type of information provided in premarket applications, as long as the information is appropriate and sufficient to meet regulatory standards. It will give flexibility to the approval,” said the MDMA. “To that end, when finalized, we will revise the draft guidance to allow manufacturers to provide validation information in lieu of validation test data where appropriate, and to extend the scope of information to clinically relevant human resources. It should be limited to factor information.”
“And manufacturers should instead be able to show that their devices have labels that are identical or consistent with labels already approved by authorities for the same type of device. A new device is potentially a ‘new device’ but should not raise the issue of new or different human factors,” the group added.
MDMA points out that there are other tools at the FDA’s disposal to address the HF issue. As an example, the agency’s Quality System Regulation (QSR) says it can help uniquely address issues such as design verification and device labeling. The group adds that the Medical Device Reports (MDR) can be used to ensure heart failure issues are being addressed in the postmarket setting.
“FDA must also continue to rely on existing authorities, including inspection authorities, to further our common goal of ensuring the safety and effectiveness of medical devices and protecting them from risks associated with use errors. ‘ said MDMA.
AdvaMed, a medical device lobby group, also raised questions about certain aspects of the draft guidance. The way agencies worded their documentation is that all device marketing submissions, including those that do not have a critical task, must include Human Factors/Usability Engineering (HF/UE) information, and that sponsors must It claims to suggest that HF verification should be performed for . product. The group said this was too burdensome and changed the wording to clarify that a device with no critical tasks need not transmit his HF information or perform HF verification. suggested to do
AdvaMed also argues that the FDA’s proposed 60-day timeline for implementing the guidance is too short.
“This guidance includes substantive changes to submission definitions and requirements that require updating quality system documents and processes prior to implementation,” said the group. “Additionally, this guidance provides details that may need to be incorporated into a product development process that can span years.”
AdvaMed said the FDA should give sponsors at least one year to conduct gap assessments of products in development and implement updates to the HF process.
The Combination Products Coalition (CPC) has also submitted comments on the draft guidance. A draft of the guidance was prepared by the Center for Devices and Radiological Health (CDRH) and the Office of Combination Products (OCP), but the group did not clarify how it plans to use the guidance for drug-driven combination products. The guidance applies to all FDA-formulated products, regardless of whether drugs, medical devices, or biologics lead the way.
“In general, the CPC notes that publishing different HF guidance documents from CDRH and CDER will create uncertainty in the industry and affect our ability to get our products to patients in need. I would like to,” said CPC. “Manufacturers are unsure whether guidance from the CDER is the sole governing guidance for all drug-driven combination products, regardless of the complexity of the device components … This will impact how products are developed. It makes a difference and creates expectations and confusion of inconsistent reviews.”
“Having a unified HF guidance document from CDRH, CDER and CBER will eliminate confusion and promote a consistent approach for both pharmaceutical companies and their partnering medical device manufacturers.” group added. “However, if coordination between centers cannot be achieved due to differing considerations for drugs and medical devices, having a more clearly defined scope can reduce uncertainty.”
