MDUFA Small Business Program, Registration and Listing

Description

This is the first module of a series.

This is a module produced by the FDA that describes some of the basics you need to know as you are thinking about heading to the U.S. market. This module consists of:

• An Introduction to FDA’s Regulation of Medical Devices
• How is CDRH Structured?
• Is My Product a Medical Device?
• Medical Device User Fee Amendments of 2017 (MDUFA IV): An Introduction