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...
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...
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...
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...
