Human factors guidance: Stakeholders ask for clarity, less burdensome approach

Industry groups have challenged several aspects of the US Food and Drug Administration’s (FDA) recent draft guidance on the human factors (HF) information in medical device marketing submissions. While the agency describes its approach as “risk-based” in the guidance, one industry group suggested changes to that approach to reduce the burden on device makers.
 
In December, FDA published an updated draft guidance on HF content in device submissions, which the agency says can help it better understand any potential risks for user errors and how to potentially mitigate them. While the agency has said it is using a risk-based approach in the proposed guidance, the Medical Device Manufacturers Association (MDMA) disagreed in its public comments. (RELATED: FDA proposes framework for human factors information in device submissions, Regulatory Focus 12 December 2022)
 
MDMA says that while it appreciates that FDA typically takes a risk-based approach in its regulatory processes, as well as a least-burdensome approach as directed by Congress, it argues that the guidance fails to achieve those objectives.
 
“MDMA believes that elements of the draft guidance inappropriately depart from this broader risk-based approach, are inconsistent with the principles underlying the premarket review framework, and will result in the agency focusing its limited resources on human factors information that is not tailored to addressing those circumstances with the highest risk to patients,” MDA said. “Although the draft guidance purports to adopt a ‘risk-based approach,’ the draft guidance provides that the presence of new or changed critical tasks will determine the human factors information required in a premarket application, ignoring other relevant factors that should inform a risk-based determination.”
 
MDMA said it is concerned the draft guidance will substantially expand the scope of medical device premarket applications where FDA will ask for HF information and the result will be an increase in pre-submission meetings with the agency about what is considered necessary HF information. It argues that this will not only be unnecessarily burdensome for the sponsors but will put more strain on FDA’s limited premarket review resources.
 
MDMA also argues that FDA should consider device types when evaluating the level of risk from HF when evaluating a product. The groups said the guidance should take into consideration the type of HF information needed to support premarket applications and clarify that the nature of the information it needs for its regulatory decisions.
 
“An appropriate risk-based approach consistent with the existing statutory and regulatory framework would also grant manufacturers flexibility with respect to the type of information provided in a premarket application, so long as the information is appropriate and sufficient to meet the statutory and regulatory standards for authorization,” said MDMA. “To that end, the draft guidance, if finalized, should be revised to provide that manufacturers may provide verification information in lieu of validation testing data, where appropriate, and should limit the scope of information to clinically relevant human factors information.”
 
“It should also provide that manufacturers may instead show that their device has labeling identical to or consistent with labeling that has already been authorized by the agency for a device of the same type, because although such devices are potentially ‘new devices,’ they do not raise new or different human factors issues,” the group added.
 
MDMA notes that there are other tools at FDA’s disposal to address HF questions. As an example, it said the agency’s Quality System Regulation (QSR) can help independently address issues such as design validation and device labeling. The group adds that Medical Device Reports (MDRs) can be used to ensure HF issues are being addressed in the postmarket setting.
 
“FDA should also continue to rely on its existing authorities, including its inspectional authorities, to facilitate our shared goal of ensuring the safety and efficacy of medical devices and protecting against the risks associated with use errors,” MDMA said.
 
The medical device lobby group, AdvaMed, also took issue with certain aspects of the draft guidance. It argues that the way the agency worded the document suggests that marketing submissions for all devices, including for those with no critical tasks, need to include human factors/usability engineering (HF/UE) information and sponsors need to perform HF validation for all their products. The group said this would be overly burdensome and suggested a change in the language to clarify that devices without critical tasks do not need to submit HF information or conduct HF validation.
 
AdvaMed also argues that FDA’s 60-day suggested timeline to implement the guidance is far too short.
 
“This guidance includes substantive changes to definitions and requirements for content of submission that will require updates to quality system documents and processes prior to implementation,” said the group. “In addition, this guidance provides details that may need to be incorporated into the product development process, which can be several years long.”
 
AdvaMed said that FDA should give sponsors at least one year to conduct gap assessment of their products in development and implement updates to their HF processes.
 
The Combination Products Coalition (CPC) also submitted comments on the draft guidance. While the draft guidance was developed by the Center for Devices and Radiological Health (CDRH) and the Office of Combination Products (OCP), the group asked the agency to clarify how it plans to use the guidance for drug-led combination products and recommended the guidance apply to all FDA combination products regardless of whether they are led by drugs, devices or biologics.
 
“Generally, CPC would like to note that publishing different HF guidance documents from CDRH and CDER creates uncertainty in industry and impacts our ability to deliver products to patients in need,” said CPC. “Manufacturers are uncertain if guidance from CDER is the sole governing guidance for all drug-led combination products, regardless of complexity of the device constituent part … This creates differences in the way the products are developed, as well as inconsistent review expectations and confusion.”
 
“Having unified HF guidance documents from CDRH, CDER, and CBER would eliminate confusion and drive a consistent approach for both drug manufacturers as well as medical device manufacturers partnering with drug companies,” the group added. “However, if alignment between centers is not achievable due to different considerations for drugs and medical devices, having more clearly defined scope could reduce uncertainty.”