FDA
The new article provides an overview of the guidance document describing the approach to be applied with respect to information the authority expects to be included in submissions for a specific type of product. Table of Contents The Food and Drug Administration (FDA...
IMDRF
The new article highlights the aspects related to the limited support stage of the total product life cycle and provides recommendations to be followed by the parties involved. Table Of Contents: The International Medical Device Regulators Forum (IMDRF), a voluntary...
FDA
The new article highlights the aspects related to how an applicant should submit requests for feedback and explains the approach to be applied with respect to combination products. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
Europe
The new article describes in detail the approach to be applied with respect to notifications, databases, liability insurance, and other aspects related to performance studies involving in vitro diagnostic medical device Table of Contents The Swiss regulating authority...
FDA
The article provides an overview of the questions and answers document issued by the US regulating authority and highlights the key points related to Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in healthcare...
