FDA Medical Device Registration and Listing

Failed to REGISTER with FDA !!!
July 9, 2014
US FDA MEDICAL DEVICE Establishment Registration
September 9, 2014

Medical devices are classified into Class I, II, and III.

All the devices need to register with USFDA before marketing in USA.

Most Class I devices are exempt from Premarket Notification 510(k) AND most Class II devices require Premarket Notification 510(k), before registration and Listing

The basic regulatory requirements that manufacturers of medical devices distributed in the U.S.A must follow and comply Read More about further activities and Medical Device Establishment Registration

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