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.
FDA
The article provides an overview of the regulatory framework for additional notifications related to medical devices.
FDA
The article addresses the aspects related to the authority’s expectations associated with the respective program.
FDA
The article describes in detail the approach to be applied for credibility factors and credibility goals to be considered by the parties responsible for medical devices.
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