HPRA
The article addresses the aspects related to the fees payable in the context of authorization for medical device manufacturers, wholesalers, and distributors.
FDA
The article highlights the key points associated with the electronic submissions template described by the US authority.
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.
