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: 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.
Medical devices are divided into Classes I, II and III.
The FDA review process takes 90 days for 510(k), 30 days for 513(g) and 180 days for PMA.
Annual establishment registration is required.
A United States agent is required.
Last updated on February 15, 2017.
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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