US FDA Human Factors Guidance and eSTAR 7.0: August 2026 Regulatory Update

The US Food and Drug Administration (FDA) has implemented a new risk-based framework for presenting human factors information in medical device marketing submissions. The final guidance, Content of Human Factors Information in Medical Device Marketing Submissions, was issued in May 2026 and became effective on August 1, 2026.

FDA has also incorporated the guidance content into Version 7.0 of both the non-in vitro diagnostic (nIVD) and in vitro diagnostic (IVD) electronic Submission Template and Resource (eSTAR). Manufacturers preparing a US medical device or IVD submission should now verify that their use-related risk analysis, human factors evidence, and eSTAR responses are aligned before filing.

Which submissions are affected?

The Human Factors Content Guidance addresses the information FDA recommends including in:

• Premarket notifications under section 510(k).
• De Novo classification requests.
• Premarket approval applications (PMAs).
• Humanitarian device exemption (HDE) applications.

The framework is intended to improve consistency and support efficient FDA review. It complements FDA’s existing guidance, Applying Human Factors and Usability Engineering to Medical Devices, rather than replacing the underlying usability-engineering process.

For eSTAR, FDA requires the template for most 510(k) and De Novo submissions to CDRH or CBER, including applicable combination-product submissions and dual 510(k)/CLIA Waiver IVD submissions. Use of eSTAR remains voluntary for the PMA application and supplement types listed by FDA, as well as for Q-Submissions, IDEs, and 513(g) requests.

What has changed in eSTAR 7.0?

The current nIVD and IVD eSTAR Version 7.0 templates include content from the new Human Factors Content Guidance. This means human factors planning is no longer only a standalone report-preparation activity; it must also be reflected accurately in the structured submission template.

Applicants should pay particular attention to the consistency between:

• The intended users, use environments, and use scenarios described across the submission.
• The use-related risk analysis (URRA) and identified critical tasks.
• The rationale for the human factors validation approach.
• The validation study design, user groups, training conditions, and results.
• Device labeling, instructions for use, risk controls, and residual use-related risks.
• The answers selected in eSTAR and the supporting attachments provided for each question.

Inaccurate eSTAR responses can omit relevant questions or place a submission on technical screening hold. Manufacturers should therefore treat completion of the template as a controlled regulatory activity supported by the same approved evidence used in the technical documentation.

Practical impact for medical device and IVD manufacturers

The update is particularly relevant to products with complex user interfaces, home-use settings, lay users, software-driven workflows, alarm functions, connected features, or safety-critical tasks. However, a low-complexity device should not automatically be assumed to have no human factors documentation requirements. The appropriate documentation level should follow the device’s use-related risk profile.

Manufacturers planning a US market submission should assess the impact early. Discovering gaps after design verification or validation can lead to additional studies, labeling revisions, risk-management updates, or delayed filing.

August 2026 readiness checklist

Before submitting with eSTAR 7.0, regulatory and product teams should confirm that they have:

1. Identified all intended user groups, use environments, operating conditions, and reasonably foreseeable use scenarios.
2. Maintained a traceable URRA that links use-related hazards, hazardous situations, critical tasks, risk controls, and validation evidence.
3. Defined whether a human factors validation study is required and documented the regulatory rationale.
4. Reconciled human factors findings with design controls, ISO 14971 risk-management records, labeling, and instructions for use.
5. Used the current FDA eSTAR template and checked every answer against the final supporting documents.
6. Completed an independent submission-readiness review before the eSTAR is finalized and uploaded through the appropriate FDA portal.

How CMS Medtech can support US market access

CMS Medtech supports medical device and IVD manufacturers with US regulatory pathway assessment, submission planning, technical documentation review, eSTAR preparation support, human factors documentation gap assessment, and coordination of evidence required for FDA premarket submissions.

An early, integrated review can help align regulatory strategy, usability engineering, risk management, labeling, and submission content before formal filing.

Official FDA resources

• Content of Human Factors Information in Medical Device Marketing Submissions
• FDA eSTAR Program

This article is a general regulatory update and does not constitute product-specific legal or regulatory advice. Submission requirements should be confirmed against the current FDA resources and the characteristics of the device or IVD.