When a manufacturer desires to make a change to a Class III device that has been approved via a Premarket Approval (PMA) or product development protocol (PDP) that affects the device’s safety and effectiveness (new indication for use, a change to the labeling, new manufacturing site, etc.) or a change to a Humanitarian Device Exemption (HDE) that affects its safety and probable benefit, a supplement application is required.

Some of the brightest novel products across industries are originating from existing – or old inventions. Innovation does not have to be born of a zero starting block.

Some of the brightest novel products across industries are originating from existing – or old inventions. Innovation does not have to be born of a zero starting block.

Have you struggled to develop your search strategies for the state of the art evaluation? Are you finding yourself sorting through large amounts of data? This article outlines best practices for creating the state of the art evaluation under EU regulations.