Priory Analysts compiles submissions for the US regulatory authorities (the FDA), both the 510(k), IDE and PMA. For this service, precedence is given to existing CE marking customers.
For mid-risk devices the route to FDA ‘approval' is the 510(k) route, in which the manufacturer has to demonstrate that the device is equivalent to a device already on the market. It is called a pre-market ‘notification' rather than a pre-market approval.
For completely new devices and higher risk devices a Pre Market Application (PMA) is required.
Both types of ‘approval' require that the manufacturer institute and maintain a quality system to the requirements of the Quality System Regulation (QSR). This is broadly based on the 1987 and 1994 editions of ISO 9001. With suitable skill a single quality system can embrace EU and US requirements.

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