Submitting for an approval for a medical device through the FDA can be a stressful and anxious time. It is important to understand the most recent recommendations from the agency. Too often these recommendations are given through feedback from the submission process itself, making a proactive approach difficult. In this presentation we will review recent FDA suggestions from real 510k submissions. These suggestions will touch on all aspects of the ISO 10993 standard series from cytotoxicity, sample preparation, E&L, toxicology, and more.