Significant and Nonsignificant Risk Medical Devices

Beschreibung

This comprehensive resource explains the FDA's classification of devices and provides expert guidance on differentiating between significant risk and non-significant risk medical device studies. The book is divided into two parts: Significant Risk Medical Devices and Non-Significant Risk Medical Devices. Each chapter includes a general introduction and overview of the device, along with guidance on its working principles, beneficial and toxicological effects, and potential risks to the health and safety of a patient/subject. The coverage also includes reports of prior investigations on the basics of risk determination and the nature of potential harm associated with using individual devices. Significant and Non-Significant Risk Medical Devices is designed to assist practicing engineers, academic researchers, and clinical investigators in navigating the complex regulatory environment associated with medical device research and development.An essential resource for researchers and professionals in the medical device field;Thoroughly covers the distinctions between Significant Risk (SR) and Non-Significant Risk (NSR) device studies;Presents simplified guidelines and regulatory points.
This comprehensive resource explains the FDA's classification of devices and provides expert guidance on differentiating between significant risk and non-significant risk medical device studies. The book is divided into two parts: Significant Risk Medical Devices and Non-Significant Risk Medical Devices. Each chapter includes a general introduction and overview of the device, along with guidance on its working principles, beneficial and toxicological effects, and potential risks to the health and safety of a patient/subject. The coverage also includes reports of prior investigations on the basics of risk determination and the nature of potential harm associated with using individual devices.

Significant and Non-Significant Risk Medical Devices is designed to assist practicing engineers, academic researchers, and clinical investigators in navigating the complex regulatory environment associated with medical device research and development.

Autor*in

Prakash Srinivasan Timiri Shanmugam

Themen in »Significant and Nonsignificant Risk Medical Devices«

Biomedical research Clinical research Medical device design Significant Risk Device (SR) Nonsignificant Risk Device (NSR) Food and Drug Administration (FDA) Investigational Device Exemptions (IDE) IDE 21 CFR 812 IDE 21 CFR 812.2(b) Institutional Review Boards (IRB) Medical and health technologies Medical device industry Medical device standards

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