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# Human Factor Guidance is FDA ‘Mission Creep’: Attorney
- URL: https://www.fdaweb.com/human-factor-guidance-is-fda-mission-creep-attorney/
- Published: 2023-02-23T12:00:00.000Z
- Updated: 2026-09-14T18:17:09.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153841

An FDA 12/9/22 draft guidance, [*Content of Human Factors Information in Medical Device Marketing Submissions*](https://www.fdaweb.com/draft-device-human-factors-guidance/), “seems like mission creep” for FDA to go beyond the stated primary purpose to impose a dramatic expansion of the requirement. That’s the view of attorney **Jeffrey Shapiro** (Hyman, Phelps & McNamara), who says the agency says the primary purpose of the guidance is to smooth 510(k) reviews by providing more granular information about how to address the human factors (HF) requirement.

Writing in his firm’s *FDA Law Blog*, Shapiro [says](https://www.thefdalawblog.com/2023/02/the-new-fda-draft-human-factors-guidance-a-bridge-too-far/?ref=fdaweb.com) the draft “imposes a major policy change with far-reaching implications. Simply saying that the approach is ‘risk-based’ is not adequate justification. The costs and uncertainty of this expansion to HF requirements are significant. The countervailing need for the change, however, is not well documented.”

The issue, the post says, is that as currently drafted, it appears that the new guidance dramatically expands the number of 510(k) submissions that require HF data. “The threshold is set extremely low,” Shapiro writes. “If there is one ‘critical task’ identified for a new or modified device, HF data must be addressed in some fashion…. To put it another way, the only valid justification for not including human factors data for a new device is that there are no critical tasks.” (A “critical task” is defined as a user task which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care.)

Shapiro argues that the draft guidance is at odds with the fundamental purpose of the 510(k) program, which he says is to enable an efficient risk-based process for FDA review and clearance of low- to moderate-risk devices.

“The draft guidance can be fixed by simply deferring to existing requirements as to when HF data are required (e.g., as a *de novo* special control or in a guidance document for a specific device type,” he concludes.