Why does the FDA want companies to submit a URRA instead of a Use FMEA?

On our website we sell a usability procedure (SYS-048). The procedure cost is $299, and the procedure includes the following documents:
1. SYS-048 Usability Procedure
2. TMP-030 Summative Usability Study Protocol
3. TMP-040 Use-Related Risk Analysis (URRA) Template
4. TMP-041 Human Factors Usability Report Template
5. URRA Template from FDA 2022 Draft Guidance (Table 2)
➤ www.medicaldev...
We updated TMP-040 to match the FDA draft guidance, and the Excel spreadsheet has the same table, but no explanation is included.

[@josephakyeampong6745]

Thanks for sharing. What is the Severity of Harm column based on - i.e., a severity score (e.g. 0 to 5) or classification (e.g. High, Medium, Low)?

[@MedicalDeviceAcademy]

In the examples provided in ISO/TR 24971:2020, specifically Clause 5.5, there are examples of qualitative, quantitative, and semi-quantitative estimation of risks. You could use either approach. Before the risk management team begins the risk estimation process, the team should agree on a scale to use (a scale of 1-5 is most popular). This should be documented in your risk management file. In addition, the scores will need to be reviewed whenever you receive post-market feedback. The PMS data may indicate that your original scoring was inaccurate and should be revised.
You should not use the term "classification" for risk estimates or the components of severity or probability, but it is ok to use qualitative estimates with the words high, medium, and low. The term "classification" should be reserved for things like software risk classification (i.e., A, B, C) or device risk classification (i.e., 1, 2, 3 or 1M, 1S, 1R, 2a, 2b, and 3).

[@josephakyeampong6745]

@@MedicalDeviceAcademy Thank you!

[@user-in8fx9rc9c]

Thanks for this info! Ours is a Class II prescription device. Could you please tell me in which section I should upload the usability engineering report in eSTAR V5.1?

[@MedicalDeviceAcademy]

January 8, 2024 the FDA released v5.1 of the nIVD and IVD eSTAR templates. The only change to each of these templates is the addition of Hydrogen Peroxide as a Category A sterilization method instead of a Category B sterilization method.
Regarding your question, the usability engineering file should be added to the benchtop performance testing section of the submission. In neither template do they have questions about the human factors, but there is a note in the nIVD template as a Java Script window for help next to the button for attaching benchtop testing reports. The last line item says, "Usability/Human Factors: Studies specifically assessing the instructions and/or device design in terms of impact on human behavior, abilities, limitations, and other characteristics, on the ability of the device to perform as intended should be included here."

[@user-dv6ei9kk5l]

Hi, thanks for the info. I'm curious where might the word Use FMEA originates from.

[@MedicalDeviceAcademy]

As with many things in the regulatory world, there are acronyms. However, this acronym is not the fault of the FDA. Instead, the FMEA acronym dates back to military use, NASA, aerospace, and automotive standards that were developed after World War II (i.e., 1960s and 1970s). The full name is "Failure Modes and Effects Analysis."
They even have a standard specifically for this method of risk analysis:
webstore.ansi.org/standards/iec/iec60812ed2018?gad_source=1&gclid=CjwKCAjwqMO0BhA8EiwAFTLgIAxYQJkAmqEnqSY9aX31PgH87SoN6htY7KRz5Wnq3kcfuiXMTNUiihoCpDgQAvD_BwE
The basic approach is "bottom-up." The team involved makes a list of all the components. Then they brainstorm how each component might fail. Then they estimate the severity of clinical harm that might occur when that component fails. Next the probability of occurrence of harm is estimated. Finally, the detectability of the failure mode is estimated. The three factors are multiplied to create a risk score. Then you document risk controls you plan to implement and adjust the probability and detectability based upon the effectiveness of risk controls.

[@user-dv6ei9kk5l]

@@MedicalDeviceAcademy Thanks for awesome detailed reply! So Use FMEA is just FMEA related to Use or Usability, right? In South Korea, its Ministry of Food and Drug Safety have introduced the concept of Use FMEA , and describes its approach as "Top-down" in their recent guidance. But I haven't seen the description like it from 62366, or the above you mentioned, and the FDA in what I read. Maybe it's a method they locally made up. Anyway thank you very much.