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.
Last updated on November 23rd, 2021.
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.
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