One of the most efficient ways to get a medical device to the US market is with a 510(k) application. A 510(k) is an application to the US FDA claiming that a device a manufacturer intends to place on the market is 'substantially equivalent' to a currently marketed device in the US. The US FDA has introduced a program by which designated companies can review certain moderate to low risk products and provide a recommendation to the FDA to allow the 510(k) to be issued. The reason for the program is to speed devices to market by providing quicker turn around for 510(k) reviews. To prepare 510(k) paperwork is complex and time consuming. By working alongside a third-party, such as SGS, we can help to shorten the process to get your 510(k) medical device cleared through the premarket notification. As a recognized third party review organization, SGS is allowed to review medical devices as listed on the FDA website. This webinar will explain more.
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