Regulatory Control on Medical Devices - A Case Study on Device Recalls by USFDA
DOI:
https://doi.org/10.56042/jipr.v27i3.46322Keywords:
Medical Devices, Recall and Recall Strategy, USFDA, Degree of Risk, Health Hazard, CFR, FDA LawAbstract
The aim of the case study is to reflect on the FDA regulations on the Medical Devices, aspects of classifying the risk
caused by the devices and to study the process of recalls by the companies strategically followed by the regulatory authority.
Further, a case study was performed to identify the medical devices that were recalled in the year 2020, to investigate the
reason for the recall, the subsequent effects on the system and further actions to rectify the problems. The study emphasized
various reasons for the medical devices recalled during the year 2020. It warns the companies and users to follow the
conditions strictly during their manufacture and trials which would minimize the errors of the functioning of the medical
devices in the mere future. Also the study alerts the medical practitioners about the precautions and safe instructions to be
followed during the installation and utilization of the devices.
