FDA
The new article describes in detail the aspects related to the regulatory status of medical device development tools in comparison to medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
FDA
The new article provides an overview of the main points highlighted by the authority in terms of the applicable regulatory requirements and also outlines the aspects to be taken into consideration when following the applicable rules. Table of Contents The Food and...
FDA
The new article highlights aspects related to the second stage of the application review process and also describes the approach to be applied when making changes to a tool after its qualification. Table of Contents The Food and Drug Administration (FDA or the...
FDA
The new article describes in detail the matters related to MR compatibility and also provides a brief overview of non-clinical testing and the way it should be conducted. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
FDA
The new article addresses aspects related to the initial proposal and the way it will be assessed by the authority during the acceptance review. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
FDA
The new article highlights aspects related to pyrogenicity, (accelerated) aging, packaging, ensuring that the sterility of the device is duly maintained, as well as biocompatibility for all the components and patient-contacting materials. Table of Contents The Food...
