FDA Finalizes Guidance on Human Factors Data in Device Marketing Submissions

The US Food and Drug Administration has finalized guidance on what human factors information device makers should include in marketing submissions, replacing a revised draft issued in December 2022. The agency published the final guidance on May 28, Regulatory Focus reported, and a notice of availability appeared in the Federal Register on May 29.

According to the notice, the purpose of the guidance "is to provide a risk-based framework to guide manufacturers and FDA staff on the human factors information that should be included in a marketing submission to CDRH to facilitate the efficiency of the FDA review process." Regulatory Focus reported that it applies to device marketing submissions including 510(k) premarket notifications, De Novo requests and premarket approval applications. The docket number is FDA-2015-D-4599.

A long path to final

The guidance traces back to February 2016, when FDA issued a draft titled "List of Highest Priority Devices for Human Factors Review," according to the Federal Register notice. After stakeholder feedback, the agency issued the revised draft, "Content of Human Factors Information in Medical Device Marketing Submissions," on December 9, 2022, which replaced the 2016 document. FDA said it considered comments on the 2022 draft and added risk-based factors for determining the human factors submission category, new illustrative examples and appendices, and clarifications to the guidance's scope.

The notice says the final guidance is meant to complement FDA's existing guidance "Applying Human Factors and Usability Engineering to Medical Devices."

What is new

Regulatory Focus reported that FDA added a decision point on whether human factors validation test data should be submitted, weighing the interface history of the intended use and environment, the complexity of the user interface and the adequacy of existing risk controls. Sponsors should assess the use-related risk analysis when considering that decision point, the agency said.

"For modified devices where critical tasks are impacted by the modification but existing risk control measures remain effective at eliminating or reducing the risk, submitters can consider providing a rationale in lieu of submitting new human factors validation testing," FDA wrote, according to the publication. "Such rationale should include objective evidence that the risk controls remain effective."

New examples for modified 510(k) devices include a reusable duodenoscope, a stereotaxic navigation system, a continuous glucose monitor and an interoperable automated glycemic controller for type 1 diabetes, Regulatory Focus reported. Three appendices illustrate what a human factors report should contain for HF Submission Categories 1, 2 and 3. The guidance notes that combination products carry additional considerations it does not address.

FDA said in the Federal Register notice that the agency and industry "may need a minimum of 60 days to perform activities to operationalize the policies within this guidance." For submissions pending at publication and those received before August 1, 2026, FDA "generally does not anticipate that manufacturers will be ready to include the newly recommended information," though it intends to review such information if submitted at any time.

The document represents FDA's current thinking and is not binding on FDA or the public, the notice says.