Overview of the USA FDA Classification Process

 

Classification is arguably one of the most important steps in the US FDA medical device approval process. Understanding how the US FDA classifies devices and the tools available to you is critical for identifying the proper regulatory pathway in the United States. Choosing the wrong device class could cost you considerable time and money, and result in regulatory or legal actions.

In this short video we cover the classes of medical devices, provide examples of navigating the classification database, discuss Product Codes and Regulation Numbers, and provide useful tips to consider as you research your device.

You may also like:

Understanding the US FDA Device Classification System Understanding the US FDA Device Classification System
Free White Paper.

 

How long will it take my 510(k) to be cleared by the US FDA? How long will it take my 510(k) to be cleared by the US FDA?
Free online calculator provides average times the FDA takes to clear a product code for sale.

 

Medical Device Regulations for Turkey US FDA Registration Process for Medical Devices
Free flow chart provides a brief overview of how the PMA and the FDA 510(k) process work. The chart shown illustrates the FDA approval process in USA and is available for download in PDF format.

 

Return to the list of all videos.