The FDA’s updated eSTAR v7.0 submission template now embeds stricter human factors requirements for medical devices, shifting the focus from whether a validation study was conducted to whether the device’s use-related risk is acceptable. The change reflects a deeper regulatory emphasis on usability engineering as a core part of device safety, not just an afterthought.
For manufacturers, this means the old approach—treating human factors as a late-stage checkbox—no longer suffices. The FDA’s 2026 guidance clarifies that validation studies are only one way to demonstrate risk mitigation. If a device’s foreseeable misuse could cause severe harm, testing is typically required. If not, the justification must still be documented in the usability engineering file. The key shift: the FDA wants to see the entire process, not just test reports.
Risk category, not device type, now drives the rules
The FDA categorizes devices into three risk-based tiers, not by product code or prior approval history. Category 1 covers minor backend changes, like algorithm updates to existing software, that don’t alter the user interface or workflow. These rarely trigger new human factors requirements.
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Category 2 is where most manufacturers now operate. It includes devices with no critical tasks (where misuse wouldn’t cause severe harm) or modifications that don’t affect critical interactions. Even here, the burden of proof has risen. A Use-Related Risk Analysis (URRA) is now mandatory for nearly every new submission, along with a Known Use Problem Search (KUPS) report to scan public databases for misuse patterns in similar devices. Clinician testimony or formative data showing alignment with standard of care can help justify a Category 2 classification, but assertions alone won’t cut it.
How device risks trigger Category 3 scrutiny
A device can slip into Category 3—triggering full validation testing, if modifications introduce critical tasks or shift the user from home settings to clinical environments. For example, a home in vitro diagnostic (IVD) test might start as Category 2: a false result could cause unnecessary stress or minor delays. But if the same test is repurposed for hospital use, misreading results could lead to misdiagnosis or delayed treatment, pushing it into Category 3. The FDA’s focus here is on harm potential, not just technical changes.
This isn’t just about new devices. Even modified products now face closer scrutiny. If a software update changes how clinicians interpret results, or if a hardware revision alters workflows, the FDA may demand a comparative user interface analysis, even if the changes seem minor. The expectation is clear: manufacturers must prove their updates don’t introduce new risks, not just assert that they don’t.
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Documentation, not testing, is the new priority
For teams with submissions in the next 30 to 90 days, the priority is documentation, not last-minute testing. A robust usability engineering file—including a detailed URRA and review of FDA adverse event reports—can strengthen a Category 2 claim. If prior submissions relied on minimal human factors evidence, now is the time to audit gaps before the FDA flags them during review. Waiting for a deficiency letter to act is riskier than proactively aligning with the new expectations.
The FDA’s updated guidance shifts the focus from whether a validation study was conducted to whether the device’s use-related risk is acceptable. This means manufacturers must now justify their classification, whether Category 1, 2, or 3, through a detailed usability engineering file, not just test reports. For devices already on the market, this often requires retroactive documentation to align with the new expectations. The FDA’s emphasis on risk-based categorization means even minor modifications can trigger a reclassification if they introduce critical tasks or alter user workflows.
For Category 2 devices, the burden of proof has grown significantly. The FDA expects a detailed use specification outlining intended users, environments, and training requirements, elements often overlooked in legacy submissions.
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Clinical data as usability evidence with strict rules
In some cases, clinical study data can serve as usability evidence, but only if the usability protocol is integrated into the study design from the outset. Observations of real-world use are mandatory, and self-reported errors must be supplemented with direct observations if the study doesn’t allow for them. This approach is most viable for devices where simulated testing can’t replicate actual conditions, such as ablation tools or surgical instruments used in dynamic clinical settings.
The FDA’s eSTAR v7.0 template now includes mandatory fields for human factors documentation, including URRA summaries and KUPS findings. Devices submitted under older templates may face automated rejections if these fields are incomplete.
