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Device Classification & Regulatory Pathway – XPRO AMERICA

Proper device classification and regulatory pathway determination are essential first steps for marketing medical devices in the United States. The FDA classifies devices as Class I, II, or III, based on risk level, intended use, and regulatory controls. Choosing the correct submission route 510(k), De Novo, or PMA (Premarket Approval)—is [...]

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US FDA 510 (k) Registration

US FDA 510 (k) Registration Features included in your subscription: The U.S. Food and Drug Administration (FDA) 510(k) registration process is specifically related to the clearance of medical devices. The 510(k) pathway is used to demonstrate that a new medical device is substantially equivalent to a predicate device that is [...]

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