With a continued focus on ensuring the health and safety of patients throughout the US and beyond, the FDA released in early 2016 a guidance entitled, "Applying Human Factors and Usability Engineering to Medical Devices" and, executives throughout the industry are focusing on meeting the suggested standards. Core areas within the document of interest include assessing the user of medical products, of particular concern for organizations manufacturing products that may have an array of users, up to and potentially including patients, understanding the appropriate scope of usability testing and acceptable levels of sample size is of great importance. With a wide range of standards and regulations impacting human factors, FDA experts responsible for human factors review take a risk-based approach to meeting standards as well as ensuring the safety of products.
- Considerations of user groups per FDA guidance
- Granularity requirements in testing sample populations
- Continually reducing risk and increasing safety
Michelle Jackson, Partner, Venable LLP
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