Aug 16, 2023
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...
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Aug 16, 2023
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...
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Aug 15, 2023
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...
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Aug 15, 2023
FDA
The new article highlights aspects related to the MDDT program, its intended purpose, and its benefits. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance...
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Aug 14, 2023
FDA
The new article highlights aspects related to sterility and reprocessing for both sterile and non-sterile. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published draft...
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