
FDA Draft Guidance on Third Party Review Program: Documentation and Reporting
The new article describes in detail the approach to be applied concerning documenting the review process, its completion, and reporting.
The new article describes in detail the approach to be applied concerning documenting the review process, its completion, and reporting.
The new article addresses the aspects related to various matters associated with the licensing process for establishment licenses.
The new article highlights the aspects related to the classification rules applicable to specific categories of healthcare products.
The new article highlights the aspects related to the review process itself.
The article provides a general overview of the classification framework for medical devices.