Medical Device Registration and Approval in USA

General country-specific regulatory information is provided on this page for medical device registration and approval in USA. Become a LICENSALE.COM user to receive detailed device-specific compliance information for each market, including USA, to expedite the preparation of your medical device or IVD registration application.

Medical Device Regulations and Classification in USA

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.

For more information on Medical Device Registration in USA, check out the following articles:

5 things to know about upcoming FDA guided requirements

Case study 5 questions & answers: recent requirements for medical devices in the USA

Other North American Countries:

Canada, Mexico

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