MDCG
The article provides an overview of the revised guidance document addressing the classification rules. Table Of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission responsible for the medical devices regulatory framework,...
FDA
The new article covers the matters related to antigen diagnostic tests and explains the approach to be applied by the test developers in order to ensure the continued effectiveness of their devices. Table Of Contents: The Food and Drug Administration (FDA or the...
FDA
The new article highlights the key points related to molecular diagnostic tests and describes the recommendations provided by the authority in this respect. Table Of Contents The Food and Drug Administration (FDA or the Agency), the UA regulating authority in the...
FDA
The new article highlights the aspects related to the way the impact of viral mutations can be addressed when developing tests. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products,...
FDA
The article describes the approach to be applied with respect to viral mutations and their potential impact on the performance of tests intended to identify the virus. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority...
