US FDA has various mechanisms to facilitate interaction with the Agency regarding various applications that can be submitted for medical devices of varied risk classes. The early engagement with the Agency is facilitated through the request for feedback or a meeting with the US FDA under the “FDA Q-Submission Consulting Program”. This program enables interaction with the FDA on study and data considerations to improve the quality of submissions, reduced review timelines, and avoidance of unnecessary pre-clinical or clinical studies. Furthermore, manufacturers can leverage the FDA pre-submission meeting and FDA Q-submission consulting services to enhance their comprehension of regulatory prerequisites and optimize their submission strategies for maximum effectiveness.