Medical device makers use the 510k premarket notification to legally market a new medical device. This procedure necessitates the submission of technical data to the Food and Drug Administration (FDA) on a prescribed form known as a Premarket Notification (510k) Application, which is then examined by FDA scientists for safety, effectiveness, and labelling. A company’s 510k submission is a crucial document. It certifies to the agency that your product complies with public health and safety regulations, allowing you to list it as an FDA-approved device on your marketing labels.