Background: Need for Medical devices is 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 the USA, a regulatory
body known as FDA (Food and Drug Administration) has its unit called CDRH which
looks the manufacture, packaging and use of medical devices in the USA.
Objective: In USA, Medical devices are classified into 3 classes: class I which look for the
medical devices used for the general control as dental floss and bandages, etc., class II which
regulate the medical devices used for the general control as well as special control as powered
wheelchairs and pregnancy kits. Class III medical devices look the general control.
PMA (Premarket Approval) and Premarket Notification application has been filed to FDA
for seeking the market authorization of medical devices. We perform clinical trials for medical
device which are quite different from 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
make the researcher aware of the regulation and clinical trials of medical devices in the USA.
Conclusion: Every medical device should comply with FDA, QMS and QSR for marketing
in the USA. The present article has focused on the regulation of medical devices, clinical trial
phases and clinical studies on medical devices.