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

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. 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, URL: https://www.ijtsrd.com/papers/ijtsrd59800.pdf Paper Url:https://www.ijtsrd.com/other-scientific-research-area/other/59800/a-review-on-approval-process-and-regulation-of-medical-devices-as-per-us-fda-and-cdsco/navya-g