Final guidance issued by FDA CDRH on May 29, 2026 (finalizing the December 2022 draft) that provides a risk-based framework for the human factors information to include in 510(k), De Novo, PMA and HDE submissions; combination products are not addressed. Submitters determine one HF Submission Category per submission using a flowchart based on the use-related risk analysis (URRA): whether the device is a modification; whether the user interface, intended users, uses, use environments, training or labeling change; whether there are critical tasks (new or impacted, for modified devices); and whether human factors validation data are needed given the user interface history of use, its complexity and the adequacy of existing risk controls. Category 1 calls for a conclusion and high-level summary; Category 2 adds a rationale and descriptions of users, uses, environments, training, the user interface and known use problems; Category 3 calls for a full HFE/UE report including the URRA, critical tasks and human factors validation testing. Worked examples are included; for instance, a change to a computer-assisted detection algorithm with no user interface change falls into Category 1. The guidance is a companion to Applying Human Factors and Usability Engineering to Medical Devices. FDA generally does not anticipate the newly recommended information in submissions pending at publication or received before August 1, 2026. Docket FDA-2015-D-4599.

FDA CDRH issued final guidance on the collection and submission of patient preference information (PPI). It includes recommendations on study design, validation, and the integration of PPI across the total product life cycle, and provides a roadmap for sponsors incorporating the patient perspective into regulatory submissions.