The FDA 510(k) submission is a crucial step for manufacturers seeking to introduce or modify medical devices in the U.S. market. This process ensures that a device is substantially equivalent to one already legally marketed in the U.S., thereby demonstrating its safety and effectiveness. While it is not as https://holdenbtgsd.wikimeglio.com/9450959/navigating_the_fda_510_k_submission_process_for_medical_devices