Africa
The new article highlights the aspects related to the classification rules to be applied with respect to in vitro diagnostic medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA) has published a guidance document dedicated...
FDA
The new article describes in detail the procedure to be followed when submitting a request under the Q-Submission framework. In particular, the authority pays attention to the content of submissions. Table of Contents The Food and Drug Administration (FDA or the...
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...
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...
