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A Review on Approval Process and Regulation of Medical Devices as Per US FDA and CDSCO

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A Review on Approval Process and Regulation of Medical Devices as Per US FDA and CDSCO


Navya G | Veeresh N | Sumita Debnath



Navya G | Veeresh N | Sumita Debnath "A Review on Approval Process and Regulation of Medical Devices as Per US FDA and CDSCO" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-7 | Issue-4, August 2023, pp.775-779, URL: https://www.ijtsrd.com/papers/ijtsrd59800.pdf

The approval process and regulation of medical devices constitute a crucial aspect of ensuring patient safety, efficacy, and the availability of innovative healthcare solutions. This comprehensive review examines the approval procedures and regulatory frameworks for medical devices in two prominent regulatory agencies: the US Food and Drug Administration (FDA) and the Central Drugs Standard Control Organization (CDSCO) in India. The article provides insights into the evolving landscape of medical device regulations, beginning with an overview of the key definitions and classifications employed by both agencies. A detailed exploration of the pre-market approval pathways, including 510(k) clearance and premarket approval (PMA) in the US, and the various classes and application types in India, sheds light on the rigorous evaluation processes medical devices undergo. The review also delves into the post-market surveillance and vigilance mechanisms implemented by the FDA and CDSCO, emphasizing the importance of continuous monitoring to identify and mitigate potential risks associated with medical devices. Comparative analysis between the two regulatory bodies elucidates the nuances in terms of regulatory requirements, timelines, and pathways, reflecting the diverse healthcare landscapes they serve. The challenges and future directions in medical device regulation are also addressed, including the need for harmonization, rapid technological advancements, and the importance of global collaboration. Ultimately, this review underscores the significance of robust regulatory frameworks in fostering patient safety, fostering innovation, and ensuring the accessibility of safe and effective medical devices on a global scale.

medical devices, FDA, CDSCO, approval process, regulatory framework, patient safety, innovation, pre-market approval, post-market surveillance, challenges, future directions


IJTSRD59800
Volume-7 | Issue-4, August 2023
775-779
IJTSRD | www.ijtsrd.com | E-ISSN 2456-6470
Copyright © 2019 by author(s) and International Journal of Trend in Scientific Research and Development Journal. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0) (http://creativecommons.org/licenses/by/4.0)

International Journal of Trend in Scientific Research and Development - IJTSRD having online ISSN 2456-6470. IJTSRD is a leading Open Access, Peer-Reviewed International Journal which provides rapid publication of your research articles and aims to promote the theory and practice along with knowledge sharing between researchers, developers, engineers, students, and practitioners working in and around the world in many areas like Sciences, Technology, Innovation, Engineering, Agriculture, Management and many more and it is recommended by all Universities, review articles and short communications in all subjects. IJTSRD running an International Journal who are proving quality publication of peer reviewed and refereed international journals from diverse fields that emphasizes new research, development and their applications. IJTSRD provides an online access to exchange your research work, technical notes & surveying results among professionals throughout the world in e-journals. IJTSRD is a fastest growing and dynamic professional organization. The aim of this organization is to provide access not only to world class research resources, but through its professionals aim to bring in a significant transformation in the real of open access journals and online publishing.

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