Sep 28, 2023
Australia
The article highlights the aspects related to the regulatory framework for telecommunication products, radiation-emitting medical devices as well as the software used to power healthcare products. Table of Contents The Therapeutic Goods Administration (TGA), an...
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Sep 27, 2023
FDA
The article highlights the aspects related to the rights and responsibilities of Institutional Review Boards in the context of informed consent. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere...
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Sep 27, 2023
Asia
The article addresses the aspects related to elements of the submission template associated with the device description and information about the product to be provided by the applicant for the authority to be able to conduct a review. Table of Contents The...
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Sep 27, 2023
FDA
The article addresses the aspects related to the responsibilities of the parties involved in clinical investigations, namely, study sponsors and clinical investigators. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
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Sep 26, 2023
Australia
The new article highlights the aspects related to Class IIb spinal implantable medical devices and also highlights some other points related to the recent changes to the applicable classification rules impacting the regulatory status of spinal implantable medical...
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