FDA The article provides an overview of the applicable regulatory requirements concerning the manufacturing facilities. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
FDA The new article provides an overview of the specific regulatory requirements for quantitative imaging function in medical devices, including the aspects related to labeling, as well as to different types of functions depending on the user’s input required (manual,...
FDA The new article describes in detail the scope of information to be included in premarket submissions concerning quantitative imaging. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
FDA The new article addresses specific matters related to the non-clinical performance testing, and regulatory requirements associated thereto. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
FDA The article provides an overview of the regulatory requirements related to radiological devices and certain aspects associated thereto. Table of Contents The Food and Drugs Administration (FDA or the Agency), the US regulating...
