Regulatory Open Forum

Is it acceptable/common to collect usability data during an Animal Study? 

We have a product very similar to the predicate. 

We would like to justify HFcategory 2  (FDA)  can we use the animal study to collect the data?  

Is it acceptable/common to collect usability data during an Animal Study? 

We have a product very similar to the predicate. 

We would like to justify HFcategory 2  (FDA)  can we use the animal study to collect the data?  

Hi ,

Category 2 of the FDA's Human Factors guidance refers to medical devices that have moderate-to-high user interface risk. This means that the device's user interface could pose a potential risk to the safety and effectiveness of the device if not properly designed, tested, and validated. Examples of Category 2 medical devices include infusion pumps, patient monitors, and surgical instruments.

Yes, the Human Factors (HF) Category 2 designation can be used to guide the usability study of medical devices with moderate-to-high user interface risk. In fact, usability testing is one of the key activities recommended by the FDA's HF guidance for Category 2 medical devices, as it provides critical insights into how users interact with the device and helps identify potential use-related hazards. The results of the usability testing should be documented in a Human Factors Engineering/Usability Engineering Report.

Is it acceptable/common to collect usability data during an Animal Study? 

We have a product very similar to the predicate. 

We would like to justify HFcategory 2  (FDA)  can we use the animal study to collect the data?  

Raje,

Since FDA says that Category 2 devices require no "critical" tasks (i.e., they involve no user tasks which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care), could you give more explanation about your assertion that Category 2 devices instead have "moderate-to-high" user interface risk?

Hi ,

Category 2 of the FDA's Human Factors guidance refers to medical devices that have moderate-to-high user interface risk. This means that the device's user interface could pose a potential risk to the safety and effectiveness of the device if not properly designed, tested, and validated. Examples of Category 2 medical devices include infusion pumps, patient monitors, and surgical instruments.

Yes, the Human Factors (HF) Category 2 designation can be used to guide the usability study of medical devices with moderate-to-high user interface risk. In fact, usability testing is one of the key activities recommended by the FDA's HF guidance for Category 2 medical devices, as it provides critical insights into how users interact with the device and helps identify potential use-related hazards. The results of the usability testing should be documented in a Human Factors Engineering/Usability Engineering Report.

Is it acceptable/common to collect usability data during an Animal Study? 

We have a product very similar to the predicate. 

We would like to justify HFcategory 2  (FDA)  can we use the animal study to collect the data?  

Hi Kevin, While it is true that Category 2 devices do not involve critical tasks, it does not mean that they do not have moderate-to-high user interface risks. Category 2 devices may require the user to interact with the device's user interface to perform tasks that, if performed incorrectly, could lead to adverse events or compromised medical care.

For example, a Category 2 device could be a blood glucose meter that requires the user to enter the correct information, such as the date and time, before performing a glucose test. If the user enters incorrect information, it could result in inaccurate test results, leading to incorrect treatment decisions and compromised medical care.

Another example of a Category 2 device is a medication dispensing system that requires the user to enter the correct dosage and medication information. If the user enters incorrect information, it could result in the wrong medication being dispensed, leading to adverse events and compromised medical care.

Therefore, while Category 2 devices do not involve critical tasks, they still have moderate-to-high user interface risks that need to be carefully considered and mitigated to ensure patient safety.

Raje,

Since FDA says that Category 2 devices require no "critical" tasks (i.e., they involve no user tasks which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care), could you give more explanation about your assertion that Category 2 devices instead have "moderate-to-high" user interface risk?

Hi ,

Category 2 of the FDA's Human Factors guidance refers to medical devices that have moderate-to-high user interface risk. This means that the device's user interface could pose a potential risk to the safety and effectiveness of the device if not properly designed, tested, and validated. Examples of Category 2 medical devices include infusion pumps, patient monitors, and surgical instruments.

Yes, the Human Factors (HF) Category 2 designation can be used to guide the usability study of medical devices with moderate-to-high user interface risk. In fact, usability testing is one of the key activities recommended by the FDA's HF guidance for Category 2 medical devices, as it provides critical insights into how users interact with the device and helps identify potential use-related hazards. The results of the usability testing should be documented in a Human Factors Engineering/Usability Engineering Report.

Is it acceptable/common to collect usability data during an Animal Study? 

We have a product very similar to the predicate. 

We would like to justify HFcategory 2  (FDA)  can we use the animal study to collect the data?