Regulations on Pharmaceutical Products and Medical Devices in USA

B. Ranganayakulu*, P. Lakshmi Gurunath Kumar¹, Dr. S Mohammed Yusuf², Dr. A. Srikanth³, C. Venugopal Rao^{4
*, 2, 4} Associate Professor, Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P., India
¹Srinivasa Institute of Pharmaceutical Sciences, Proddatur, A.P., India
³Assistant Professor, Vasavi Institute of Pharmaceutical Sciences, Kadapa, A.P., India

A B S T R A C T
The United States (U.S.) regulates medical devices using a classification system based on the risk to the patient from using the device. Medical devices are classified into Class I (least risk), II, and III (most risk). Regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type. Most Class I devices are exempt from any clearance or preapproval requirement before they can be sold in the U.S. In other words, Class I devices can generally be sold without preapproval. Most Class II devices must receive prior clearance from the FDA before they can be sold in the U.S. The clearance process is known as “premarket notification” (the manufacturer notifies the FDA of its intention to market the device) and the application is referred to as a “510(k) application” based on the section of the U.S. Food, Drug and Cosmetic Act (FDCA) which authorizes the process. Most Class III devices must undergo a more exacting and expensive process, typically requiring clinical trials, known as “premarket approval” (PMA) before they can be sold in the U.S.
Keywords: Medical devices, FDA, FDCA, PMA.