Regulatory Pathway for Class I Medical Device Elastic Bandage in Usa

Abstract

Regulatory body of medical device in the globe is USFDA. According to USFDA in USA medical devices are enforced by CDRH- Centre for Devices and Radiological Health. In USA medical device Regulatory pathway varies based on intended use. Depending on the risk of patient medical devices in USA are divided into 3 classes. Class 1 medical devices are low risk devices. The example of class 1 medical devices is Elastic Bandages is having different regulatory pathway and approval process. To get FDA approval of Elastic Bandage is does not require premarket notification 510(k) and PMA (pre-Market Approval) due to low risk device class, the steps involved in approval from FDA for class 1 devices are device registration, listing, and fee payment, which are must be renewal for every year