HSA Guidance on Product Registration Submission Preparation: Device Description and Summary
The new article outlines the scope of information to be included in the device description and executive summary sections of the submission.
The new article outlines the scope of information to be included in the device description and executive summary sections of the submission.
The new article highlights specific aspects of a clinical investigation plan, such as the approach to be followed concerning the deviations or informed consent and how it should be obtained before commencing a study.
The first article of the cycle provides a brief overview of the Safety and Performance Based Pathway, the ideas behind it, and key underlying concepts. The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices,...
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published guidance describing the most important aspects related to testing and labeling of medical devices for safety...
The Food and Drug Administration (FDA) has published guidance dedicated to the self-monitoring blood glucose test systems intended for over-the-counter use. Important Notes The document represents a final version of the document issued previously in November 2018. The...