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://crm-for-real-estate-agent21985.wikiusnews.com/1103917/fda_510_k_submission_process_for_medical_devices_a_comprehensive_guide