FDA
The present article provides additional details regarding specific aspects related to the policy for monkeypox tests, including the ones related to validation, serology tests, and also the availability of EUA templates. Table of Contents The Food and Drug...
Australia and Oceania
The new article describes in detail the approach to be applied concerning comparable devices including substantially equivalent devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...
FDA
The new article describes the particular way the least burdensome provisions should be applied to facilitate and streamline the regulatory processes associated with placing medical devices on the US market. Table of Contents The Food and Drug Administration (FDA or...
EU MDR/IVDR
The new article provides an overview of the medical device classification rules adopted in the European Union and highlights the key points associated thereto. Table of Contents The Borderline and Classification Working Group (BCWG), a subgroup of the Medical Device...
FDA
The present article describes in detail the aspects related to modifications to tests already approved for use in the US, as well as the ones related to the content of notification and reporting. Table of Contents The Food and Drug Administration (FDA or the Agency),...
