May 1, 2023
FDA
The new article highlights the aspects related to the applicable policy and outlines the key points to be taken into consideration. Table of Contents The Food and Drug Administration (FDA), the US regulating authority in the sphere of healthcare products, has...
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Apr 18, 2023
Europe
The article highlights the key points related to the regulatory requirements for performance studies involving in vitro diagnostic medical devices. Table of Contents Swissmedic, a Swiss Agency for Therapeutic Products, has published an information sheet dedicated to...
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Apr 18, 2023
FDA
The new article highlights the aspects related to the general approach to the changes related to software products and also describes the most important concepts used. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
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Apr 17, 2023
FDA
The article highlights the key points related to monitoring clinical investigations as prescribed by the applicable legislation. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products,...
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Apr 17, 2023
North America
The article provides additional details regarding the approach to be applied with respect to certain types of medical devices in terms of regulatory flexibility. Table of Contents Introduction The Food and Drug Administration (FDA), a Philippines regulatory agency in...
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