Record Details

Regulatory Control on Medical Devices - A Case Study on Device Recalls by USFDA

NOPR - NISCAIR Online Periodicals Repository

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Field Value
 
Title Regulatory Control on Medical Devices - A Case Study on Device Recalls by USFDA
 
Creator Kamisetti, Raja Rajeswari
 
Subject Medical Devices
Recall and Recall Strategy
USFDA
Degree of Risk
Health Hazard
CFR
FDA Law
 
Description 190-201
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.
 
Date 2022-06-29T11:06:09Z
2022-06-29T11:06:09Z
2022-05
 
Type Article
 
Identifier 0975-1076 (Online); 0971-7544 (Print)
http://nopr.niscpr.res.in/handle/123456789/59974
 
Language en
 
Publisher NIScPR-CSIR, India
 
Source JIPR Vol.27(3) [May 2022]