Makers of medical devices shouldn’t view the US Food and Drug Administration’s (FDA) new final guidance on human factors information in marketing submissions as a substitute for broader design control and quality system requirements, agency officials say.
Responding to industry questions about “Content of Human Factors Information in Medical Device Marketing Submissions” at a July 22 Town Hall webinar, FDA officials stressed that the document is narrowly focused on recommending what human factors information should accompany medical device marketing submissions to the agency’s Center for Devices and Radiological Health (CDRH).
They pointed out that the final guidance, issued on May 29, doesn’t change manufacturer obligations under the FDA’s new Quality Management System Regulation (QMSR), which incorporates international quality systems standard ISO 13485:2016 by reference.
“The HF content guidance provides recommendations on what human factors information to include in marketing submissions to CDRH,” said Anthony Maiorana, Acting Team Lead for the FDA’s Human Factors Team in the Office of Product Evaluation and Quality (OPEQ). However, he noted that meeting QMSR requirements “is not within the scope of this guidance.”
Instead, Maiorana said manufacturers should continue documenting their internal risk management, human factors engineering, and design optimization activities, as those records can support human factors information submitted to the agency. (Related Story: “Usability Engineering and Control of Medical Device Risk Due to User Error,” QualityHub, July 11, 2023.)
Submission Categories Don’t Change Human Factors Expectations
Another area of clarification involved the FDA’s new human factors submission categories.
Andrea Fiala, a General Engineer on the Human Factors Team, said the categories affect only the amount of documentation the agency expects to receive in a marketing submission, not the underlying human factors work manufacturers should conduct.
“The specific level of human factors documentation recommended in your submission is what the human factors submission category determines, not what human factors processes should be applied,” she said.
Fiala emphasized that companies should continue applying human factors and usability engineering throughout device development regardless of whether human factors validation data ultimately accompany a submission.
Human factors should be integrated into design, development, and risk management activities for all medical devices, she said, adding that manufacturers subject to ISO 13485’s Design and Development requirements (Clause 7.3) should rely on internal quality system procedures to determine when human factors validation testing is appropriate.
No Universal Definition of ‘Complex’ Device Interface
The FDA officials also addressed questions about one of the guidance’s more subjective concepts: device user interface complexity.
Maiorana said establishing a single regulatory definition would be impractical because complexity depends on multiple factors, including intended users, use environments, and technological characteristics.
A device may present different levels of complexity in a “hospital versus a home setting,” he said, noting that emerging technologies such as software, interoperability, artificial intelligence, and adaptive algorithms continue to change how complexity should be evaluated.
Rather than creating a rigid definition, FDA intentionally adopted a risk-based framework that allows manufacturers to evaluate complexity within the context of each device.
Human Factors Applies Broadly
The FDA officials also addressed questions about whether certain categories of devices are automatically exempt from, or automatically require, human factors and usability engineering activities. Their answer was no.
Fiala said the agency doesn’t establish blanket exemptions or mandates based on device type. Instead, manufacturers are expected to meet the Design and Development requirements of ISO 13485, including incorporating usability engineering activities that are appropriate for the device’s intended use.
Even when human factors information isn’t included in a marketing submission, Fiala said the FDA recommends that manufacturers maintain documentation of the work performed. She emphasized that the guidance’s risk-based approach is intended to streamline the amount of information submitted to the agency, not reduce the human factors activities conducted during product development.
The officials also cautioned manufacturers against using the new guidance to determine whether a device modification requires a traditional 510(k) or another pre-market submission pathway.
Instead, Fiala said companies should continue relying on the FDA’s existing 510(k) guidance documents when evaluating whether changes to a marketed device trigger a new submission.
Risk Analysis Should Remain a Living Document
Addressing questions about Use-Related Risk Analysis (URRA), Maiorana said the FDA expects device makers to maintain comprehensive, living risk analysis documents that evaluate both critical and non-critical user tasks.
He said a URRA’s “Validation Method” section should contain information that provides traceability to final validation testing, even though not every task will necessarily be included in a human factors validation study.
Human factors validation should include all necessary tasks and present them in a logical workflow, Maiorana said, consistent with the FDA’s existing 2016 guidance, “Applying Human Factors and Usability Engineering to Medical Devices.”
