FDA Lists Devices to Include Human Factors Data in PMA & 510(k) Submissions

On Wednesday, FDA released a draft guidance entitled “List of Highest Priority Devices for Human Factors Review.” The draft guidance was published by FDA’s Center for Devices and Radiological Health (CDRH) and provides a list of the types of medical devices that should include human factors data in premarket submissions, such as PMA and 510(k) applications.

Devices Included in the List

CDRH “has identified circumstances under which human factors validation testing should be submitted in a premarket submission,” and says that the devices listed in the document were selected based on their “clear potential for serious harm resulting from use error.” Furthermore, the specified devices have been identified “based on knowledge gleaned through Medical Device Reporting (MDRs) and recall information.”

The devices included in the list are:

• Ablation generators (associated with ablation systems, e.g., LPB, OAD, OAE, OCM, OCL)
• Anesthesia machines (e.g., BSZ)
• Artificial pancreas systems (e.g., OZO, OZP, OZQ)
• Auto injectors (when CDRH is lead Center; e.g., KZE, KZH, NSC)
• Automated external defibrillators (e.g., MKJ, NSA )
• Duodenoscopes (on the reprocessing; e.g., FDT) with elevator channels
• Gastroenterology-urology endoscopic ultrasound systems (on the reprocessing; e.g., ODG) with elevator channels
• Hemodialysis and peritoneal dialysis systems (e.g., FKP, FKT, FKX, KDI, KPF ODX, 107 ONW)
• Implanted infusion pumps (e.g., LKK, MDY)
• Infusion pumps (e.g., FRN, LZH, MEA, MRZ )
• Insulin delivery systems (e.g., LZG, OPP)
• Negative-pressure wound therapy (e.g., OKO, OMP) intended for use in the home
• Robotic catheter manipulation systems (e.g., DXX)
• Robotic surgery devices (e.g., NAY)
• Ventilators (e.g., CBK, NOU, ONZ)
• Ventricular assist devices (e.g., DSQ, PCK)

CDRH states that having the human factors data included in premarket submissions will help them evaluate the devices’ safety and effectiveness, as well as substantial equivalence. However, it also states that this data is not required if “the submission does not involve any changes to users, user tasks, user interface, or use environments from those of the predicates.”

Using the List for Premarket Submissions

The draft guidance provides instructions on how the list should be used in premarket submissions, stating that:

“Any premarket submission for the devices listed above should include either a human factors test report and data as described in ‘Applying Human Factors and Usability Engineering to Medical Devices,’ or should provide a detailed rationale that supports the conclusion that human factors data are not necessary.”

Devices that are not included in the list only need to include human factors data in premarket submissions if a risk analysis of the device finds that failure to perform tasks, or performing them incorrectly, has the potential to result in serious harm to the user. CDRH’s Office of Device Evaluation (ODE) reserves the right require human factors data on a case-by-case basis if one or more of the following apply:

• Submission type: Premarket Application (PMA) or De Novo Petition for a device that has potential for serious harm resulting from use error
• User interface modification: New or different user interface features were implemented to satisfy a special control or recommendation (in a device-specific guidance document) related to its use
• Different users: The submission includes a change of intended users, for instance the new device is intended for use by lay users when the predicates were labeled for use only by healthcare professionals and device use has potential for serious harm resulting from use error
• Recalls, adverse events, and problem reports: The device type has been associated with recalls, adverse events, problem reports or complaints for which the cause has been attributed to use error or use error is the only explanation
• Device modifications: The device was modified or differs from the predicate in any of the following ways and the device has potential for serious harm resulting from use error:
  • The user interface has been modified (even if it has been simplified)
  • User tasks have been added or changed
  • The severity of possible harm resulting from use error has increased
  • The device will be used in a new use environment (e.g., in the home or a moving vehicle)

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