The new article addresses the matters related to the information to be included in notifications the parties responsible for medical devices should submit.
RegDesk Regulatory Roundup
The article provides an overview of the regulatory framework for additional notifications related to medical devices.
The new article describes the matters related to periodic evaluations the authority intends to conduct to ensure compliance with the applicable regulatory regiments.
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FDA Draft Guidance on 510(k) Third Party Review Program and Emergency Use Authorization Review: Content and Format
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.
The article addresses the aspects related to the authority’s expectations associated with the respective program.