EDA
The new article addresses the aspects related to the minimum criteria an adverse reaction report should meet to comply with the respective requirements.
FDA
The article highlights the aspects related to clinical images to be submitted by the applicant and also describes the approach to be applied concerning modifications to medical devices covered by the scope of the guidance.
FDA
The article addresses the aspects related to possible image artifacts and the way they should be treated and also describes the approach to be applied when reporting results.
BfArM
The new article addresses the aspects related to the data security measures to be introduced by the parties involved in operations with digital health products.
FDA
The new article highlights the aspects related to the current version of the electronic submission template and outlines the key points to be considered by submitters (applicants).
HPRA
The new article addresses the matters related to medical devices and associated fees.
