CDSCO
The last article from the cycle elaborates on the applicability of the principles and approaches described in the guidance in special cases.
FDA
The article outlines the basics of chemical analysis in the context of biocompatibility of medical devices.
Swissmedic
The article outlines the approach to be applied with respect to legacy medical devices in the context of transitional provisions.
FDA
The new article provides further clarifications related to gathering additional information.
FDA
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.
FDA
The new article explains in detail the way chemical analysis should be conducted in order to ensure any and all key matters are addressed properly.
