
FDA Draft Guidance on Third Party Review Program: Evaluation
The new article describes the matters related to periodic evaluations the authority intends to conduct to ensure compliance with the applicable regulatory regiments.
The new article describes the matters related to periodic evaluations the authority intends to conduct to ensure compliance with the applicable regulatory regiments.
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 new article describes in detail the applicable classification approach and highlights the key considerations associated thereto.
The article addresses the aspects related to the authority’s expectations associated with the respective program.
The new article highlights the aspects related to the classification rules applicable to specific categories of healthcare products.