United States
The new article highlights aspects related to the description of the software to be included in submissions associated with a medical device using it. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
United States
The new article highlights aspects related to the description of the software to be included in submissions associated with a medical device using it. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
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...
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...
FDA
The new article highlights the aspects related to the language to be used for informed consent, and also to the description the authority expects the parties responsible for clinical investigations to provide to potential study participants. Table of Contents The Food...
FDA
The new article covers regulatory matters related to non-clinical animal testing and alternatives thereto, as well as clinical performance testing and the approach to be applied when determining whether it is reasonably needed to collect additional data. Table of...
