FDA
The new article describes in detail the enforcement policy introduced by the authority and also highlights the key points to be considered in order to comply with it.
FDA
The article highlights the aspects related to the first two methods of selecting predicates: for medical devices that are cleared based on well-established methods, and also for the products that meet or exceed the expectations.
FDA
The article highlights the aspects related to physical laboratory testing to be conducted by the parties responsible for magnetic resonance products to ensure they are safe and efficient when used for the initial intended purpose.
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.
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