The FDA has released a guidance for human factors engineering (HFE) in medical devices, a guidance that spans 46 pages and is not explicitly restricted to specific device types. One of the key considerations in this guidance is that it goes into effect as of Aug. 1, 2026, barely two months after issuance of the final guidance.
The FDA’s Center for Devices and Radiological Health (CDRH) published an ancestral guidance document in 2016, which
listed the highest priority guidances for agency review. That guidance listed a limited series of product types for which FDA required HFE information in premarket applications. This was followed in 2022 by a draft guidance that offered specific information about the types of HFE data that should be included in premarket application filings.
In the May 29 Federal Register notice, CDRH stated that the 2026 final guidance would be in effect 60 days after the date of the notice, which would make July 28 the compliance date for the final guidance. However, the CDRH statement indicates that Aug. 1, 2026, which is a Saturday, is the compliance date.
CDRH stated that it does not expect that manufacturers are likely to have the required HFE information prepared for premarket submissions before Aug. 1. FDA reviewers are prepared to review any HFE information for premarket submissions prior to that date, however. The final guidance applies to humanitarian device exemption applications as well as to the three traditional premarket applications, specifically 510(k)s, de novos and PMAs.
The CDRH statement also highlighted the role of a 2016 companion guidance for the application of human factors and usability engineering for medical devices. This guidance describes the various considerations in assessing the device’s user interface to address a range of considerations, such as the site of use (e.g., home versus clinical use). The 2016 companion guidance also emphasizes the role of risk management in evaluating the usability of a device, although CDRH states that ISO 14971 is of limited utility in prospectively identifying potential user error.
Given that the May 2026 final guidance would suggest that many premarket applications will require HFE information, the 2016 companion guidance will become essential for many products. The May 2026 guidance states that not all premarket applications will require HFE information, but any omission of HFE information must be accompanied by an explanation for the omission.
The guidance recommends that premarket submissions include information on the human factors validation testing when applicable, as well as a discussion of residual risks, which are risks that cannot be reasonably further reduced. The inclusion of HFE and usability testing information “may improve the efficiency of FDA review,” the guidance states, given that the inclusion of such information can reduce the likelihood that the reviewer will request additional information. It might be noted that the agency issued a questions-and-answers guidance in 2023 directed toward HFE for combination products.
The docket for the guidance includes responses from seven organizations regarding the 2022 draft, including the Advanced Medical Technology Association (AdvaMed). While the 2022 draft had included the 60-day compliance timeline, AdvaMed stated that a one-year timeline would be more practicable. Other organizations suggested at least six months, arguments that apparently failed to sway managers at the FDA. CDRH has planned a town hall meeting to review the final guidance, which is scheduled for July 22, 2026. No registration is required.