FDA (CDRH)
GUIDANCE FINAL
Applying Human Factors and Usability Engineering to Medical Devices: Guidance for Industry and Food and Drug Administration Staff
Published: 8/3/2026Detected: 8/3/2026
Summary preview
Establishes FDA expectations for applying human factors and usability engineering throughout the medical device lifecycle to reduce use-related harms and improve device safety.
Get the full analysis, free
Create a free account to see the complete summary, key takeaways, and why this matters for your products, and to get alerts like this by email.
Create free accountmanufacturing
quality
clinical
safety
labeling
#human factors
#usability engineering
#risk management
#ISO 14971
#IEC 62366-1
Official Source Document Source Verified
Access the original document directly from FDA CDRH.
More from FDA (CDRH)
- Robotically-Assisted Surgical Devices - Premarket Submissions: Draft Guidance for Industry and Food and Drug Administration Staff9/25/2026
- Electronic Submission Template for Premarket Approval Applications (PMA): Draft Guidance for Industry and Food and Drug Administration Staff9/18/2026
- Dental Curing Lights - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff9/2/2026
- Dental Composite Resin Devices - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff9/2/2026
- Hemodialysis Blood Tubing Sets - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff7/23/2026