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 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 The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other...
FDA
The article provides an overview of the regulatory requirements for medical devices used to improve glycemic control. The document constitutes a draft guidance the authority has published in order to collect feedback from industry representatives and other parties...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published guidance dedicated to feasibility and early feasibility clinical studies for certain medical devices intended to therapeutically...
