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Regulation of Medical Devices and Their Clinical Trials Studies in USA: An Update

Author(s):

Manita Jindoliya, Aakash Deep*, Vikram Saini, A. C. Rana and Rakesh Kumar Marwaha  

Abstract:


Background: Need of Medical devices are very important in the healthcare sector and related processes for global regulation. Medical devices are the apparatus or instruments which are specifically used for diagnostics and therapeutic applications. In USA, regulatory body known as FDA (Food and Drug Administration) has its unit called CDRH which look the manufacture, packaging and use of medical devices in USA

Objective: In USA, Medical devices are classified into 3 classes: class 1 which look for the medical devices used for the general control as dental floss and bandages etc., class 2 which regulate the medical devices used for the general control as well as special control as powered wheelchairs and pregnancy kits. Class 3 medical devices look the general control. PMA (Premarket Approval) & Premarket Notification application has been filed to FDA for seeking market authorization of Medical devices. We perform clinical trials for medical device which are quiet different form the clinical trials performed for drug analysis. These trials are performed on various age groups such as on paediatrics, adult and old age group commonly called phase 1,2,3,4. Regulatory approval of high-risk medical device is based on clinical studies submitted with pre-market approval. The main objective of this article is to aware the researcher regarding the regulation and clinical trials of medical devices in the USA.

Conclusion: Every medical device should be complying with FDA, QMS and QSR for marketing in USA. The present article is focused the regulation of medical devices, clinical trial phases and clinical studies on medical devices.

Keywords:

Medical Devices, Regulation, Clinical Trials

Affiliation:

Department of Pharmaceutical Sciences, Chaudhary Bansi Lal University, Bhiwani-127021, Haryana,, Department of Pharmaceutical Sciences, Chaudhary Bansi Lal University, Bhiwani-127021, Haryana,, Department of Pharmaceutical Sciences, Chaudhary Bansi Lal University, Bhiwani-127021, Haryana,, Department of Pharmaceutical Sciences, Chaudhary Bansi Lal University, Bhiwani-127021, Haryana,, Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak-124001, Haryana



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