ABSTRACT

The medical devices has been increasing dramatically in the health care industry. To safeguard human life and deliver a high-quality, secure, and useful product, it needs to be strictly regulated. Certain nations strictly adhere to regulations to satisfy the above stated requirement. Among these, US is one of the most regulated nations in the world. There is a special committee in the US to monitor and control the medical device industry. But all the medical devices don’t need to get approval from USFDA for certain type of device we can just notify the regulatory body. It achieved by comparison of the device with already available device in market. Keywords: 510(K), Pre-Market Notification, USFDA Medical device, Regulatory pathway, Application preparation
Publication date: 01/08/2024

https://ijbpas.com/pdf/2024/August/MS_IJBPAS_2024_8221.pdf

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https://doi.org/10.31032/IJBPAS/2024/13.8.8221