FDA
The article highlights the critical points associated with the existing regulatory framework for remote regulatory assessments.
EU
The article describes in detail the regulatory approach to be applied in the context of the importation and distribution of medical devices in the EU, focusing on the obligations of the parties involved.
FDA
The new article covers some specific aspects associated with the evidential expectations for implantable devices, such as human factors, clinical performance testing, and labeling.
EU
The article highlights the key points associated with interpreting specific regulatory provisions of the current European legislation in medical devices.
FDA
The article outlines the general considerations for evidentiary expectations and describes in detail the authority’s non-clinical recommendations.
