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.
Australia
The article highlights the critical points of the new classification approach to spinal implantable 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.
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