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 Table of Contents The Food and Drug Administration (FDA or the Agency) has published a draft guidance document dedicated to a predetermined change...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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Apr 10, 2023
FDA
The document highlights the key points related to the regulatory requirements for certain orthopedic devices based on the draft guidance issued by the authority. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulatory agency in the...
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Apr 6, 2023
Africa
The document highlights the key points related to the current classification rules for different types of medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA), the country’s national regulator agency, has published a...
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Mar 30, 2023
FDA
The new article highlights the aspects related to the special framework allowing face masks intended for a medical purpose to be placed on the market under a simplified procedure. Table of Contents Introduction The Food and Drug Administration (FDA or the Agency), the...
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