FDA
The article outlines the general considerations for evidentiary expectations and describes in detail the authority’s non-clinical recommendations.
FDA
The article highlights the key points associated with the concept of evidentiary expectations in the context of marketing submissions.
Turkey
The article provides a general overview of the current regulatory framework for the distribution and advertising of medical devices intended to be marketed and used in Turkey.
FDA
The article outlines the scope of information to be included in premarket submissions depending on the sterilization methods used.
FDA
The new article addresses the matters related to the information to be included in notifications the parties responsible for medical devices should submit.
EU
The new article highlights the aspects related to the existing regulatory pathway, the approach to be applied for different types and classes of medical devices, and the way the intended purpose of the device in question should be considered.
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