FDA The new article covers specific aspects related to the Voluntary Improvement Program and regulatory procedures associated thereto. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and...
FDA The new article describes in detail the activities to be undertaken in the context of participation in the Voluntary Improvement Program. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives...
FDA The article provides an overview of the regulatory measures intended to encourage medical device manufacturers to participate in the improvement of medical devices intended to be marketed and used in the US. The document constitutes a draft guidance the authority has...
FDA The new article highlights specific aspects related to the clinical studies and the way they should be undertaken to ensure the accuracy and reliability of the results, including the patient demographics, safety endpoints, and analysis. The document constitutes a...
FDA The article describes in detail the mechanisms to be used by the authority to provide its feedback regarding the device development. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
FDA The article addresses the aspects related to the study duration, and also the inclusion/exclusion criteria to be considered. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other...
