Sep 26, 2023
FDA
The new article describes in detail the approach to be applied with respect to documentation related to informed consent. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products,...
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Sep 22, 2023
FDA
The new article describes in detail the approach to be applied with respect to general operating systems and drivers used in medical devices, as well as safety measures to be taken into consideration when medical devices are intended to be connected to any network....
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Sep 22, 2023
FDA
The new article covers aspects related to additional elements of informed consent to be included where necessary. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published...
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Sep 22, 2023
FDA
The new article addresses aspects related to third-party software products used in medical devices in the context of maintenance and obsolescence. Table of Contents The Food and Drug Administration (FDA), or the Agency, the US regulating authority in the sphere...
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Sep 22, 2023
FDA
The new article addresses the FDA aspects related to the way information about risks and benefits associated with a clinical investigation should be communicated by a study sponsor to potential study participants. Table of Contents The United States Food and...
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