Human Factor Validation
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Per the relevant guidance doc:
For the results of the human factors validation testing to demonstrate safe and effective use by users in the United States, the participants in the testing should reside in the US. Studies performed in other countries or with non-US residents may be affected (positively or negatively) by different clinical practices that exist in other countries, different units of measure used, language differences that change the way labeling and training are understood, etc. Exceptions to this policy will be considered on a case-by-case basis and will be based on a sound rationale that considers the relevant differences from conditions in the US.
So it's not mandated that the study subjects be US citizens but you may be challenged if not.
For the results of the human factors validation testing to demonstrate safe and effective use by users in the United States, the participants in the testing should reside in the US. Studies performed in other countries or with non-US residents may be affected (positively or negatively) by different clinical practices that exist in other countries, different units of measure used, language differences that change the way labeling and training are understood, etc. Exceptions to this policy will be considered on a case-by-case basis and will be based on a sound rationale that considers the relevant differences from conditions in the US.
So it's not mandated that the study subjects be US citizens but you may be challenged if not.
We just had a Q Sub which included foreign subjects for part of the submission. They expected a justification for why it's okay to use foreign subjects.
For example "Subjects from Zimbabwe were used for a portion of this study. The condition under review is Malaria. The treatment provided to these subjects was directed from a US based healthcare company using such and such protocols. Although a small part of the data, this represents the global epicenter for this disease and state of the art treatment for comparison. This data applies to patients in the USA because of such and such reasons and these Pub Med studies."
For example "Subjects from Zimbabwe were used for a portion of this study. The condition under review is Malaria. The treatment provided to these subjects was directed from a US based healthcare company using such and such protocols. Although a small part of the data, this represents the global epicenter for this disease and state of the art treatment for comparison. This data applies to patients in the USA because of such and such reasons and these Pub Med studies."
samalexander200002
Starting to get Involved
The FDA does not mandate human factors testing to be conducted in the United States or to be conducted only with U.S. citizens. The FDA's guidance on human factors testing, "Human Factors and Usability Testing of Medical Devices," states that human factors testing should be conducted in a manner that is appropriate for the device and the intended use. This may include testing with representative user groups, which could include individuals from different countries and cultures. The purpose of human factors testing is to ensure that a device is safe and effective for its intended use, and the specific testing requirements will depend on the characteristics of the device and the population for which it is intended.
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