FDA Guidance on Non-Invasive Remote Monitoring Devices: Overview
The article provides an overview of the revised guidance document issued by the US authority to address certain regulatory matters and ensure legal clarity.
The article provides an overview of the revised guidance document issued by the US authority to address certain regulatory matters and ensure legal clarity.
The new article highlights the aspects related to the language to be used for informed consent, and also to the description the authority expects the parties responsible for clinical investigations to provide to potential study participants. Table of Contents The Food...
The new article covers regulatory matters related to non-clinical animal testing and alternatives thereto, as well as clinical performance testing and the approach to be applied when determining whether it is reasonably needed to collect additional data. Table of...
The new article highlights aspects related to clinical outcomes to be used in the context of studies involving devices intended to treat opioid use disorder. In particular, the article describes in detail the change in drug use as one of the possible clinical outcomes...
The new article highlights the aspects related to the testing to be conducted in order to assess the relevant mechanical performance of bone plates and screws. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...