ABSTRACT

This comprehensive review delves into the intricate regulatory landscape established by the U.S. Food and Drug Administration (FDA) for neurological devices. As innovation in neurotechnology surges, the FDA plays a pivotal role in ensuring the safety and efficacy of these devices. The abstract explores the key guidelines governing the development, testing, and market approval processes for neurological devices. It highlights the intricate balance between fostering innovation and safeguarding public health, emphasizing the FDA's commitment to facilitating advancements in neuroscience. The document elucidates the premarket pathways, encompassing the intricate steps manufacturers must navigate, such as investigational device exemptions (IDEs), premarket approval (PMA), and 510(k) clearance. Additionally, post- market surveillance and compliance requirements are scrutinized, shedding light on the FDA's vigilant oversight to monitor device performance after market entry. This review serves as a valuable resource for industry professionals, researchers, and regulatory affairs specialists seeking clarity on the evolving FDA guidelines. By elucidating the regulatory framework, it aims to empower stakeholders to navigate the intricate terrain of bringing neurological devices to market while upholding the highest standards of safety and efficacy. Keywords: 510(k), ISO, PMA, Premarket, Risk
Publication date: 01/02/2025

https://ijbpas.com/pdf/2025/February/MS_IJBPAS_2025_8763.pdf

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https://doi.org/10.31032/IJBPAS/2025/14.2.8763