Oct 12, 2023
FDA
The article provides an overview of the regulatory requirements set forth under the existing framework and highlights the key points associated thereto. Table of Contents The FDA, the US healthcare product regulatory authority, has released a guidance document...
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Oct 4, 2023
FDA
The article addresses the aspects related to the approach medical device manufacturers should apply when assessing the actual performance of their products placed on the market in the context of the Voluntary Improvement Program. Table of Contents The Food and Drug...
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Sep 27, 2023
FDA
The new article addresses the aspects related to the voluntary improvement program introduced by the US regulating authority. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
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