Mar 4, 2024
United States
The article provides an overview of the reclassification process commenced by the US medical device regulatory agency.
Also, it outlines the specifics of such a process in the context of high-risk in vitro diagnostic medical devices.
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Nov 16, 2023
FDA
The new article highlights the aspects related to the current version of the electronic submission template and outlines the key points to be considered by submitters (applicants).
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Oct 16, 2023
FDA
The new article highlights the aspects related to design considerations including control mechanisms to be implemented. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
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Oct 13, 2023
FDA
The new article highlights the aspects related to design considerations in the part of risk management. The document also provides an overview of the most important terms and concepts used. Table of Contents The Food and Drug Administration (FDA or the Agency), the...
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Oct 13, 2023
FDA
The article highlights the key points related to the regulatory status of the products in question and describes the approach to be followed. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
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