Feb 3, 2023
FDA
The new article describes the recommended content and highlights the key points to be considered in this respect. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a...
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Jan 27, 2023
FDA
The new article addresses the aspects related to the risk-based approach to human factors engineering information in marketing submissions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
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Apr 1, 2022
FDA
The new article describes specific aspects related to human factors to be considered when assessing the safety and effectiveness of medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
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Mar 28, 2022
FDA
The new article addresses specific aspects related to human factors validation testing, including the ones related to the analysis of test results, the approach to be applied concerning residual risk, and also validation testing of modified devices. ...
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Mar 22, 2022
FDA
The new article addresses the matters related to data collection and describes in detail different types of information and the ways it could be collected. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
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