Mar 18, 2022
FDA
The new article provides a brief overview of the human factors validation testing and also addresses certain specific aspects associated thereto, including the ones related to the test participants. Table of Contents The Food and Drug...
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Feb 15, 2022
FDA
The first article provides an overview of the guidance document dedicated to the human factors and the way they should be considered when developing user interfaces for medical devices. Table of Contents The Food and Drug Administration (FDA or the...
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Aug 3, 2021
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to implanted brain-computer interface (BCI) devices for patients with paralysis or amputation. Table of...
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