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 describes the approach to be followed when submitting information related to sterilizing medical devices intended to be marketed and used in the US.
FDA
The new article highlights the aspects related to the content and format of an application for initial recognition and re-recognition as a third-party 510k review organisation.
FDA
The article addresses the aspects related to the authority’s expectations associated with the respective program.
