
FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment: Overview
The article outlines the basics of chemical analysis in the context of biocompatibility of medical devices.
The article outlines the basics of chemical analysis in the context of biocompatibility of medical devices.
The new article highlights the key aspects related to the way test articles should be extracted in order to ensure the accuracy and reliability of further assessment.
The new article describes in detail the application process to be followed by the interested parties when applying for authorisations in the context of clinical trials.
The new article clarifies the regulatory requirements related to record-keeping and reporting in the context of clinical trials.
The article provides an overview of the current reporting requirements for healthcare products allowed to be used for clinical trials.