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...
Asia
The present article provides an overview of the most important aspects related to submissions for in vitro diagnostic medical devices. Table of Contents The Health Sciences Authority (HSA), Singapore’s regulatory agency in the sphere of healthcare products, has...
MHRA
The article provides a general overview of the regulatory requirements for in vitro diagnostic medical devices intended to be marketed and used in the United Kingdom. Table of Contents The Medicines and Healthcare products Regulatory Agency (MHRA), the UK...
Australia
The article provides an overview of the new classification approach adopted in Australia with respect to implantable medical devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian healthcare product regulatory authority, has...
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...
United States
The new article highlights the aspects related to compensation for participation in a clinical investigation, contact details to be communicated by study participants, and also the voluntary nature of participation and subjects’ rights associated thereto. Table...
