
FDA Guidance on De Novo Classification Process: Overview
The article provides a general overview of the regulatory framework for innovative medical devices intended to be marketed and used in the US.
The article provides a general overview of the regulatory framework for innovative medical devices intended to be marketed and used in the US.
The article provides a brief overview of the eSTAR program and the updates thereto recently published by the US authority.
The new article highlights the critical points related to the regulatory framework for novel medical devices intended to be marketed and used in the US.
The new article highlights the critical points related to the regulatory framework for novel medical devices intended to be marketed and used in the US.
The article highlights the critical points of the regulatory approach concerning specific medical devices intended to be marketed and used in the Philippines.