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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Aug 14, 2023
FDA
The new article provides an overview of a guidance document issued by the US regulatory authority and highlights the key points to be taken into consideration by interested parties with respect to the existing legal framework. Table of Contents The Food and Drug...
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Aug 14, 2023
FDA
The new article addresses matters related to clinical performance testing, labeling, and modifications. For each of the aspects, the document provides additional clarifications, highlighting the key points to be taken into consideration in order to ensure compliance...
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