This article talks about the Unique Device Identification System for Medical Devices, its timelines and regulatory requirements across various countries. Table of Contents The use of medical devices is essential in healthcare, with millions of devices being used...
This article highlights the key elements of 21 CFR 812, Investigational Device Exemptions and their impact on the medical device industry. Table of Contents The FDA oversees the regulation of medical devices in the United States to ensure their safety and...
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...
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...
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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