Abstract

REGULATORY REQUIREMENTS AND ITS COMPARATIVE STUDY OF HIGH RISK AND LOW RISK MEDICAL DEVICES IN UNITED STATES

Vishal Hitendra Parikh, Ms. Krupa Chaitanyakumar Thula*, Dr. Dilip Girishbhai Maheshwari

ABSTRACT

Medical Device becomes the essential and most important requirements for the human beings. Medical device market has been increasing its impact in the global medical device market. In United States the medical device market remains the largest medical device market in the world with the market size of around 110$ billion and it is expected to reach 133$ billion at the end of 2016. USFDA is the main regulatory authority which regulates the medical device in United States. Centre for Devices and Radiological Health (CDRH) is responsible for protecting the public health and provides the safe and effective medical devices to the public. According to the US medical device classification there are main 3 classes of medical devices based on their risk. The Class-I and II medical devices are low risk medical devices which are less life threatening than Class-III medical device which include cardiovascular medical device. The cardiovascular medical device comes under the class-3 medical device which is the high risk medical device. The cardiovascular medical devices are life threatening devices which affect the life of patient so it requires the more stringent and specific rules for the registration of medical device in the United States. This article includes the various regulatory requirements of Class-I, II (Low Risk) and Class-III (High Risk) medical device and its comparison in United States.

Keywords: FDA, CDRH, Cardiovascular Medical Device, CDRH, 510(k), PMA.