Oct 4, 2023
CDRH
This article highlights the procedure, key points and Benefits of the USFDA eSTAR Submission Programme. Table of Contents eSTAR Submission According to the FDA announcement in September, businesses can now submit premarket applications electronically via the CDRH...
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Oct 4, 2023
CDRH
This article talks about USFDA Medical Device Approval Timeline as per their Classification. Table of Contents The process of getting FDA approval for a medical device can be lengthy and complex.The time it takes for a medical device to receive FDA approval can vary...
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Oct 4, 2023
CDRH
This blog post will provide an overview of the GUDID, its purpose, how it works, and its impact on the healthcare industry. Table of Contents The FDA’s Global Unique Device Identification (UDI) Database is a pioneering initiative that has revolutionized the...
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Sep 29, 2023
FDA
The new article addresses the FDA aspects related to the way information about risks and benefits associated with a clinical investigation should be communicated by a study sponsor to potential study participants. Table of Contents The United States Food and...
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Sep 29, 2023
FDA
The article covers additional questions industry representatives may have with respect to informed consent and specific aspects associated thereto. In particular, the aspects addressed include the involvement of children and non-English speakers. Table of Contents...
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