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FDA publishes HFE Guidance documents

February 10, 2016

Consistent with its increased scrutiny of human factors engineering studies in submissions over the last 5 years, FDA has issued one final and two draft Guidance documents in the area of Human Factors Engineering (HFE) including:

  • Applying Human Factors and Usability Engineering to Medical Devices
  • Draft Guidance - Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development
  • Draft Guidance - List of Highest Priority Devices for Human Factors Review

The list of high priority devices identifies 16 types of medical devices for which FDA will require HFE data, owing to the device’s potential for use-errors that could cause severe harm.  FDA may require human factors data on additional device types that have the same potential.

The following types of medical devices made the list.

  1.  Ablation generators (associated with ablation systems, e.g., LPB, OAD, OAE, OCM, OCL)
  2. Anesthesia machines (e.g., BSZ)
  3.  Artificial pancreas systems (e.g., OZO, OZP, OZQ)
  4.  Auto injectors (when CDRH is lead Center; e.g., KZE, KZH, NSC )
  5.  Automated external defibrillators (e.g., MKJ, NSA )
  6.  Duodenoscopes (on the reprocessing; e.g., FDT) with elevator channels
  7.  Gastroenterology-urology endoscopic ultrasound systems (on the reprocessing; e.g., ODG) with elevator channels
  8.  Hemodialysis and peritoneal dialysis systems (e.g., FKP, FKT, FKX, KDI, KPF ODX, ONW)
  9. Implanted infusion pumps (e.g., LKK, MDY)
  10. Infusion pumps (e.g., FRN, LZH, MEA, MRZ )
  11. Insulin delivery systems (e.g., LZG, OPP)
  12. Negative-pressure wound therapy (e.g., OKO, OMP) intended for use in the home
  13. Robotic catheter manipulation systems (e.g., DXX)
  14. Robotic surgery devices (e.g., NAY)
  15. Ventilators (e.g., CBK, NOU, ONZ)
  16. Ventricular assist devices (e.g., DSQ, PCK)

In addition, FDA specifically drafted a separate guidance document to outline how HFE should be applied to Combination Products, which call for coordination among multiple Centers within the agency to perform a complete review of various types of submission (e.g., IDE, IND, BLA, NDA, 510(k), ANDA).

The new Guidance on Applying Human Factors updates the previously issued Guidance.  It is available online at:


UL's Human Factors Engineering team has years of experience providing advanced HFE solutions for device manufacturers around the world.  Our team has tested hundreds of devices, many of which are listed in FDA’s list of high priority devices warranting rigorous HFE.  In addition to joining the webinar, please feel free to reach out to UL's HFE team to help interpret the new guidance and its impact on your go to market plans.

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