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.
FDA
The article provides an overview of the regulatory framework for additional notifications related to medical devices.
EU
The new article highlights the aspects related to the content of the clinical investigation report, discusses additional considerations associated with the transitional period, and explains the status of a legal representative.
FDA
The new article describes the matters related to periodic evaluations the authority intends to conduct to ensure compliance with the applicable regulatory regiments.
