Speed up the FDA approval process with a third party 510(k) review from SGS.
A 510(k) is the most common way to place a medical device on the US market. Under a traditional 510(k) submission, you must wait 90 days before you can request a status update from the FDA.
If your medical device is low to moderate risk, a third party 510(k) review from SGS will make its journey to market quicker. With a 3P510k review, the FDA must respond to status updates from SGS, the third party, within 30 days. This will save you a significant amount of time. A 3P510k reviews allows the FDA to maintain oversight of the review process but focus its resources on higher risk devices.