Jun 12, 2023
FDA
The new article highlights the aspects related to various types of modifications to be introduced to a medical device based on the information included in the initial submission and also provides an overview of the regulatory matters associated with the Modification...
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May 24, 2023
FDA
The new article highlights the aspects related to the way changes to a change control plan could be introduced, and also provides additional explanations regarding the way the proposed modifications should be described in the respective section of a plan. Table of...
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May 24, 2023
FDA
The new article addresses the aspects related to the way the need in a new marketing submission should be determined and to the implementation of modifications. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the...
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May 1, 2023
FDA
The new article highlights the aspects related to the applicable policy and outlines the key points to be taken into consideration. Table of Contents The Food and Drug Administration (FDA), the US regulating authority in the sphere of healthcare products, has...
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Apr 18, 2023
FDA
The new article highlights the aspects related to the general approach to the changes related to software products and also describes the most important concepts used. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
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