United States Of America
General country-specific regulatory information is provided on this page. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, free of charge, to expedite the preparation of your medical device or IVD registration application.

REGULATORY AUTHORITY
: The US Food and Drug Administration (FDA) is responsible for the pre-market approval of all medical devices, as well as overseeing the manufacturing, performance and safety of those.

CLASSIFICATION SYSTEM: Medical devices are divided into Classes I, II and III.

TIMEFRAME: The FDA review process takes 90 days for 510(k), 30 days for 513(g) and 180 days for PMA.

LICENSE VALIDITY: Annual establishment registration is required.   

AUTHORIZED REPRESENTATIVE: A United States agent is required.

Last updated on February 15, 2017.



Interested in obtaining fast market approval for your medical device or IVD in the United States? REQUEST A FREE QUOTE>

For more information on registration in the United States, check out the following articles on our blog:
5 Questions and Answers: New FDA GUDID Requirements
Case Study: Finding the Golden Mean for Class III Medical Device Registration with the USA FDA
5 Questions and Answers: Recent Requirements for Medical Devices in the USA
 
 
 
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