FDA Guidance on General Considerations for Animal Studies: Introduction
The new article provides an overview of the regulatory framework for animal studies involving medical devices.
The new article provides an overview of the regulatory framework for animal studies involving medical devices.
The new article highlights the aspects related to applications for provisional admission for testing.
The present article describes in detail the policy followed by the authority concerning specific supplements.
The article highlights the aspects related to data evaluation, appraisal, and also to the reports to be prepared by the parties responsible for clinical evaluation.
The new article addresses the aspects related to the sources of data used in the context of clinical evaluation of medical devices.