FDA
The new article highlights aspects related to the role and responsibilities of the US regulatory authority with respect to informed consent to be obtained before commencing clinical investigations involving human subjects. Table of Contents The Food and Drug...
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,...
Asia
The new article addresses aspects related to the way conformity to the applicable Essential Principles should be demonstrated and also outlines the key points to be considered when providing a general device description. Table of Contents The Health Sciences Authority...
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....
MHRA
The new article highlights aspects related to the in-house manufacture of in vitro diagnostic medical devices. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority in the sphere of healthcare products,...
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...
