CLINICAL TRIALS IN MEDICAL DEVICES: REGULATORY, ETHICAL, AND METHODOLOGICAL FRAMEWORKS WITH A FOCUS ON DEEP BRAIN STIMULATION

Shravan K. Yadav*, Prof. Randhawan B.B., Arya A. Shaligram, Nusratfatema K. Shaikh, Aarati B. Shinde

To ensure safety and efficacy, clinical trials for medical devices must adhere to stringent regulations, ethical standards, and rigorous scientific validation. Clinical trials for medical devices present unique challenges that are subject to thorough evaluation to ensure safety, efficacy, and regulatory compliance. This review describes the fundamental requirements for clinical trials involving medical devices, including regulatory frameworks, study design, and methodology. The essential requirements for clinical trials involving DBS (deep brain stimulation) devices include study design, patient selection criteria, ethical considerations, regulatory compliance, and risk management. Particular attention is paid to ethical issues like informed consent and patient safety, as well as the importance of interdisciplinary cooperation. Deep Brain Stimulation (DBS) is an advanced neuromodulation technique used to treat neurological illnesses such as Parkinson's disease, essential tremor, and dystonia. Conducting clinical trials for DBS devices involves particular problems because of their invasive nature, complex mechanism of action, and the necessity for long-term efficacy and safety studies. Medical device clinical trials verify that the items are made and designed in compliance with regulations. According to the conformance assessment, medical device manufacturers are primarily responsible for ensuring compliance with safety and performance requirements. Long-term follow-up, difficulties with placebo control, and device configuration are also covered. This study intends to aid in the creation of safe and efficient DBS treatments for neurological and psychiatric conditions by creating thorough criteria.