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...
Australia
The new article describes in detail the approach to be applied with respect to the changes to existing entries due to the new classification rules. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of...
United States
The new article highlights the aspects related to the marketing applications related to the products incorporating software submitted under the various legal frameworks. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
MHRA
The new article describes in detail various specific aspects related to the regulatory requirements that in vitro diagnostic medical devices are subject to. Table of Contents The Medicines and Healthcare Products Regulatory Agency (MHRA), the UK regulating authority,...
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...
