Apr 17, 2023
FDA
The article describes in detail the aspects related to the way in which comparison to a similar medical device already placed on the market is to be provided, and also on the labeling requirements to be fulfilled to ensure all the important information related to the...
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Apr 13, 2023
Uncategorized
Periodic Safety Update Reports (PSURs) are critical documents for medical device and in vitro diagnostic product manufacturers. These reports are a key component of a manufacturer’s post-market surveillance and risk management program, providing ongoing...
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Apr 10, 2023
FDA
The new article describes in detail the aspects related to the applicability of recommendations provided in the guidance in terms of medical devices and regulatory pathways. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
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Apr 10, 2023
FDA
The article outlines the key points associated with the changes to software-based medical devices marketed in the US. Table of Contents The Food and Drug Administration (FDA or the Agency) has published a draft guidance document dedicated to a predetermined change...
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Apr 10, 2023
FDA
The new article highlights the aspects related to the matters to be addressed in the description of the device included in the submission. 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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