Image Oncology: A Regulatory Perspective

Abstract

This thesis emphasizes the current regulations on image diagnostic devices in the USA, European Union, and India. In cancer, early detection is critical to reduce the death rate, so compared to other detection methods, image diagnosis devices (IDDs)are more effective for fast detection, precise tumor size detection, and no pain in usage. Computer tomography, X-rays, magnetic resonance imaging, and PET scans are imaging techniques that are essential for seeing malignancies and assisting in clinical decision-making in cancer detection. In this thesis all medical devices we have classified based on the risk associated with their intended uses per specific country regulation All IDDs have been come under moderate to high risk devices. Image device regulations like market authorization, quality management systems, clinical evaluation and investigation regulations, post-marketing surveillance, medical device reporting, and labeling requirements are review for three countries USA, European Union and India The Regulation are compare for examination of the specific requirements for radiological devices. Each country has a different market authorization application; for example, in the USA 510(k), a premarket application and a de-novo application must be required. However, in the European Union, CE (conformitte Europeenne) certification is mandatory before a device comes on the market. While In India manufacture have submit application on online porta. In these three countries, clinical trial requirements and post-marketing surveillance requirements are similar. However, all countries have established specific medical device reporting programs to ensure patient safety and effectiveness. IDD is also associated with some challenges and opportunities. The advantages of IDD include early detection, precise medicine, and the integration of artificial intelligence into devices. Regulatory bodies prioritize interpretation variability, and patient privacy and security to guarantee the safety and efficacy of IDDs. Finally, different case studies were discussed to be learned through industrial actions and regulatory authority recommendations.