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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Sep 22, 2023
FDA
The article provides a general overview of the Risk Assessment and Software testing for Off-The-Shelf Sftware as given by FDA. Table of Contents The United States Food and Drug Administration has released a guidance document about Off-The-Shelf (OTS) software...
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Sep 21, 2023
FDA
The article provides a general overview of the regulatory requirements, and also briefly describes the key concepts. Table of Contents The United States Food and Drug Administration has released a guidance document about Off-The-Shelf (OTS) software used in...
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Sep 21, 2023
FDA
The new article describes in detail the general requirements by FDA for informed consent to be followed by study sponsors and other parties involved in clinical investigations. Table of Contents The United States Food and Drug Administration (USFDA), the US...
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